Field Safety Notice: Maquet - Datascope CS100(i)_CS300 Intra­Aortic Balloon Pump (IABP)

maandag 3 juli 2017 17:00

Maquet_Getinge has received a complaint involving a CS300 IABP that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure, which has been associated to a patient death due to the failure of the device to initiate therapy.