The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.The getinge fse that discovered the issue replaced the drive manifold assembly which resolved the failure and then completed the scheduled pm.The unit passed all functional and safety tests per factory specifications, and the iabp was then returned to customer and cleared for clinical use.The initial reporter named is a getinge employee who has different contact details from that of the event site.(b)(6).The full name of the event site is (b)(6).
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