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 evaluate the iabp and was unable to reproduce the reported issue.The stm 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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