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 field service engineer (fse) that encounter the issue replaced the batteries, and performed the full pm, functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.The initial reporter named in is a getinge employee who has different contact details from that of the event site, and has the following contact information: (b)(6).
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It was reported that during a preventive maintenance (pm) performed by a getinge field service engineer (fse), the battery of the cs300 intra-aortic balloon pump (iabp) failed the battery runtime test.There was no patient involvement, and there was no adverse event reported.
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