The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.The getinge stm performing the pm replaced the front end board to correct the issue.The stm then completed pm and performed all calibration, functional and safety tests which passed per factory specifications.The iabp was then returned to the customer and cleared for clinical service.(b)(6).
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