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 service territory manager (stm) who encountered the issue replaced the backplane board as it had no audio alarm.The stm completed the pm and performed all functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.(b)(6).
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