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.(b)(6).A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The power reel cord assembly was replaced.The stm completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.
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