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.During a pm service, the getinge service territory manager (stm) discovered lines in the display when powering iabp on.To fix the issue, the stm replaced the display top assembly, additionally the stm completed the pm and replaced the critical alarm battery as it had expired.All functional and safety tests were 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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