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 engineer (stm) replaced the tether assembly and then completed the pm.The stm then performed all functional and safety tests which passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.(b)(6).
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