The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.To address the issue the getinge service territory manager (stm) replaced the helium regulator.All functional and safety tests were performed and passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.The initial reporter named is a getinge employee who has different contact details from that of the event site.Please refer to the following email and phone number: (b)(6).
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