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.A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit but did not observe a system failure in the log files, and could not duplicate the reported issue.Unrelated to the reported issue, the stm replaced the expired safety disk and completed all calibration, functional and safety tests per factory specifications.The iabp was returned to the customer and cleared for clinical service.(b)(6).
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