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<p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; color: rgb(0, 112, 192); box-sizing: border-box !important; word-wrap: break-word !important;">医疗器械不良事件信息通报（</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; color: rgb(0, 112, 192); box-sizing: border-box !important; word-wrap: break-word !important;">2015</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; color: rgb(0, 112, 192); box-sizing: border-box !important; word-wrap: break-word !important;">年第</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; color: rgb(0, 112, 192); box-sizing: border-box !important; word-wrap: break-word !important;">1-3</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; color: rgb(0, 112, 192); box-sizing: border-box !important; word-wrap: break-word !important;">期）</span></strong></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">11</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">12</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">日，</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">CFDA</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">发布《医疗器械不良事件信息通报》（</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2015</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">年第</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">1-3</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">期），分别针对医用血管造影</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">X</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">射线机、体外除颤器、低频电磁治疗设备三款产品在</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2015</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">年发现的可疑医疗器械不良事件进行通报。</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; color: rgb(0, 176, 240); letter-spacing: 2px; box-sizing: border-box !important; word-wrap: break-word !important;">医用血管造影</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; color: rgb(0, 176, 240); letter-spacing: 2px; box-sizing: border-box !important; word-wrap: break-word !important;">X</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; color: rgb(0, 176, 240); letter-spacing: 2px; box-sizing: border-box !important; word-wrap: break-word !important;">射线机</span></strong></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">医用血管造影</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">X</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">射线机，</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">也称数字减影血管造影机（</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">DSA</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">），是应用电子计算机进行辅助血管成像的</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">X</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">射线设备。医用血管造影</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">X</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">射线机通过注射造影剂突出显示血管，消除骨与软组织的影像，在临床上用于对患者的全身各部位血管的</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">X</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">射线成像，引导介入操作。医用血管造影</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">X</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">射线机一般由</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">X</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">射线发生装置、机架、导管床、影像系统等组成。</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2010</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">日至</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2015</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">6</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">30</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">日，国家药品不良反应监测中心共收到有关医用血管造影</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">X</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">射线机（以下称造影机）的可疑医疗器械不良事件</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">92</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">例，其中</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">91</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">例表现为造影机故障。这些故障主要包括无射线，设备无法启动、死机、自动关机，图像不清晰，图像不能保存，机架臂无法锁死，手术床无法移动等。其中以球管和操作台的故障报告最多，均为</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">27</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">例。典型案例如下：</span></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">案例</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">1</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">：</span></strong><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">在手术过程中造影机突然无法透视和曝光，导致患者手术无法继续进行，只好紧急将患者移至另外一台造影机下继续手术。导致手术时间延长，患者出血增多，但生命体征尚稳定。经分析该事件发生原因为球管故障，可能为球管老化所致。</span></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">案例</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">：</span></strong><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">在手术过程中造影机报警，提示球管过热自动保护，系统在短时间内禁止产生</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">X</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">射线，造成在介入手术中诊断图像的短时间中断，导致手术时间延长。经分析该事件发生原因为：机房空调自动关闭，机房过热，造成造影机的机箱温度过高。</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">因造影机主要用于在介入手术中提供影像引导，若患者已行穿刺术，且穿刺针、导丝或植入设备正在血管中时，如造影机突然发生死机、术中不显示图像等故障，无法提供影像引导，则很可能引起错误操作，对患者造成较大伤害。</span></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">风险提示</span></strong></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"></span></strong></p><hr style="" /><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">为减少不良事件重复发生造成伤害的风险，建议生产企业在产品设计中，增加对易老化、易损耗部件状态的监测，必要时增加报警信息，以便于使用者及时识别；</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">加强对医疗机构的使用培训，包括设备的操作规程、运行环境要求、易损件的使用寿命等。建议医疗机构详细阅读设备使用说明书，熟悉操作规程和使用注意事项，严格按照使用说明书的要求保证设备运行环境。</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; color: rgb(0, 176, 240); letter-spacing: 2px; box-sizing: border-box !important; word-wrap: break-word !important;">体外除颤器</span></strong></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">体外除颤器是通过电极将电脉冲施加于患者的皮肤或暴露的心脏，用来对心脏进行除颤的医用电气设备。其主要由除颤充</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">/</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">放电模块、心电信号</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">/</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">人体阻抗测量模块、充放电控制模块、心电图记录器、电源以及除颤电极板等组成。</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2010</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">月至</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2015</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">3</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">月，国家药品不良反应监测中心共收到体外除颤器可疑不良事件报告</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">231</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">份。主要表现为：心脏除颤功能失效</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">90</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">份，占报告总量的</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">38.96%</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">；监视器或记录器失效或受扰紊乱</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">52</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">份，占报告总量的</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">22.51%</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">。</span></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">典型案例：</span></strong><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2015</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">3</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">月，某医院抢救一名</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">“</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">晕倒</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">”</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">病人，当医护人员到达现场时，患者瞳孔散大，无生命体征。医护人员立即予以心肺复苏抢救，在使用除颤起搏监护仪进行心脏起搏时，蓄电池显示满电但出现除颤障碍，无法进行除颤；接入电源后，仍出现同样故障，无法实施除颤操作。最终患者抢救无效，宣告临床死亡。</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">初步分析，患者死亡与心脏除颤器失效无直接关系，但不排除由于器械失效导致延误治疗的可能。该器械失效原因为放电电路故障，医院未发现该失效的原因为未按照说明书要求进行高能量放电测试。</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">体外除颤器作为急救设备，对其进行日常维护极为重要，通过有效的机器自检和手动检测有助于提前发现绝大部分设备故障，及时发现、处理相关风险，可以避免严重伤害，甚至死亡事件的发生。</span></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">风险提示</span></strong></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"></span></strong></p><hr style="" /><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">为减少不良事件重复发生造成伤害的风险，提醒使用单位根据相关国家标准和行业标准，及所使用体外除颤器的随机文件要求，建立并严格执行体外除颤器的日常维护机制；</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">生产企业应考虑除颤器的特殊性（高风险、不常使用），尽量通过</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">“</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">机宜人</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">”</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">的设计使产品易于维护，并且加强关键部件的可靠性设计，以减少设备故障的发生。</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; color: rgb(0, 176, 240); letter-spacing: 2px; box-sizing: border-box !important; word-wrap: break-word !important;">低频电磁治疗设备</span></strong></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">低频电磁治疗设备是利用频率</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">1000Hz</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">以下低频电流产生的电脉冲效应来治疗疾病的医疗器械。该类产品主要由主机、导联线、电极等组成。临床上用于缓解疼痛、兴奋神经和肌肉、改善局部血液循环等。</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2010</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">月至</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2015</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">6</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">30</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">日，国家药品不良反应监测中心共收到该类产品有效可疑不良事件报告</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">768</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">份。经统计，此类产品的不良事件主要以电能危害为主，其中表现为人员伤害的报告</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">358</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">份，占</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">46.6%</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">，主要伤害表现为皮肤过敏、烫伤、灼伤、刺痛、疼痛及肌肉麻木等；表现为器械故障的报告</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">410</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">份，占</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">53.4%</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">，主要表现有：漏电，无输出或输出不稳定，电极片、导联线损坏等。典型案例如下：</span></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">案例</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">1</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">：</span></strong><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">患者男性，</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">65</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">岁。</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2012</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">9</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">26</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">日低频治疗仪治疗后，腰部皮肤灼伤，皮肤潮红、触痛。分析原因，可能是由于电极板老化导致输出功率过高所致。</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">案例</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">：</span></strong><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">患者男性，</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">24</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">岁。</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2014</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">11</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">日使用低频脉冲治疗仪治疗约</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">10</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">分钟，患者突然感受强烈刺激，有刺痛及触电感。分析原因，可能由于电脉冲刺激强度过大所致。</span></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">案例</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">3</span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">：</span></strong><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">患者男性，</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">6</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">岁。使用低频电子治疗仪</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">3</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">分钟后发现肌肉无明显的节律性收缩，停止治疗检查器械，发现电极片处无电流输出，更换器械。</span></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">风险提示</span></strong></p><p style=""><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"></span></strong></p><hr style="" /><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">为加强低频电磁治疗设备的安全使用，减少不良事件的发生，提醒使用者：</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">、严格控制适应症及禁忌症，按照产品使用说明书正确使用，切勿超输出功率、超时长等非正常使用，确保设备的使用环境和使用条件符合要求；</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">、加强设备的日常检查和维护保养，及时更换易损、易耗件。</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">提醒生产企业：</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">、进一步优化产品设计（如提高电极接触可靠性，加强电击伤害的防护等），提高产品安全性；</span></p><p style=""><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: Tahoma, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">2</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">、加强产品的售后维护保养服务工作和对使用者的技术支持。</span></p><hr style="white-space: normal; color: rgb(131, 104, 28); font-family: Avenir, sans-serif; line-height: 25px;" /><p style="white-space: normal; color: rgb(131, 104, 28); font-family: Avenir, sans-serif; line-height: 1.75em; text-align: center;"><span style="font-size: 14px;"></span><br /></p><p style="white-space: normal; color: rgb(131, 104, 28); font-family: Avenir, sans-serif; line-height: 1.75em; text-align: center;"><span style="font-size: 12px;">ID: </span><span style="font-size: 12px;"></span></p><p style="white-space: normal; color: rgb(131, 104, 28); font-family: Avenir, sans-serif; line-height: 1.75em; text-align: center;"><span style="font-size: 12px;">最具人气的医疗器械维修新媒体平台</span></p><p style="white-space: normal; color: rgb(131, 104, 28); font-family: Avenir, sans-serif; line-height: 1.75em; text-align: center;"><span style="font-size: 12px;">分享医疗器械前沿动态、医疗器械维修经验 </span></p><p style="white-space: normal; color: rgb(131, 104, 28); font-family: Avenir, sans-serif; line-height: 1.75em; text-align: center;"><span style="color: inherit; font-size: 12px; font-weight: inherit; text-decoration: inherit;"></span><span style="color: inherit; font-weight: inherit; text-decoration: inherit; font-size: 10px;">加群主微信 <strong><span style="font-size: 10px; color: rgb(84, 141, 212);">shanying916</span></strong> 与更多行业从业人员互动交流</span><span style="color: inherit; font-size: 1em; font-weight: inherit; text-decoration: inherit;"></span><strong style="color: inherit; font-size: 1em; text-decoration: inherit; line-height: 1.75em;"><span style="color: rgb(127, 127, 127); font-size: 12px;"></span></strong></p><p style="white-space: normal; color: rgb(131, 104, 28); font-family: Avenir, sans-serif; line-height: 1.75em; text-align: center;"><strong><span style="color: rgb(127, 127, 127); font-size: 12px;"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/A1DicCH9Vl6MoypciaNOibiaxmVLk8eA6ibKL14uWjKsZwrWboQYKTfXqPicXycwL1icfia1pAG0VzlTX3MRR4FPV0ZtZA/0?wx_fmt=jpeg" data-ratio="1.0136054421768708" data-w="147" style="float: none;" /></span></strong></p><p><br /></p>
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发表于 2020-10-21 13:08:35