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.The getinge fse that encounter the issue, replaced the cable assy, fo sensor extension and that corrected the problem.The fse then performed complete pm with full calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.Should have read (b)(6), but only the first name was inserted due to the contents exceeding maximum characters.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 cardiosave intra-aortic balloon pump (iabp) failed the fiber optic signal test with zero output.There was no patient involvement, and no adverse event reported.
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