Medical device maker Getinge is recalling 41 of its Cardiohelp Emergency Drive life support machines due to the risk of the device's emergency drive becoming stuck when clinicians attempt to activate the function. The FDA has classified it as a Class 1 recall, the most serious type. Getinge first initiated the recall in October, according to the FDA's recall notice published Dec.

医疗器械制造商Getinge正在召回其41台Cardiohelp紧急驱动生命支持机，因为临床医生试图激活该功能时，该设备的紧急驱动可能会卡住。FDA已将其归类为1级召回，这是最严重的召回类型。根据美国食品和药物管理局12月发布的召回通知，Getinge于10月首次发起召回。

8. Two models were affected that had been distributed between Sept. 14, 2022, and July 27, 2023. Overall, 41 U.S. devices were affected. Getinge issued the recall because the devices — which are used to oxygenate and remove carbon dioxide from blood to support the heart and lungs for up to six hours — have been found to be at risk of blockages or other issues preventing the emergency drive function from being turned on properly. 'The stiff hand crank is caused by a scrounger disc that interferes with the turning of the crank,' the FDA's recall notice said.

8.2022年9月14日至2023年7月27日期间发布的两个模型受到影响。总共有41台美国设备受到影响。Getinge之所以宣布召回，是因为这些用于充氧和去除血液中二氧化碳以维持心脏和肺部长达6小时的设备被发现存在堵塞或其他问题的风险，从而无法正确启动紧急驾驶功能。美国食品和药物管理局（FDA）的召回通知中说，“僵硬的手摇曲柄是由一个偷取盘引起的，它会干扰曲柄的转动。”。

'If the emergency drive is needed, a clinician may not be able to turn the handle to drive the pump or may not be able to turn the handle as fast as is needed to adequately support the patient. If this occurs, the patient will lose adequate hemodynamic support or gas exchange; the results of which could include ischemia, hypoxia, stroke, or death.'.

“如果需要紧急驱动，临床医生可能无法转动手柄来驱动泵，或者可能无法按照需要的速度转动手柄以充分支撑患者。如果发生这种情况，患者将失去足够的血液动力学支持或气体交换；其结果可能包括缺血，缺氧，中风或死亡。”。