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 stm replaced the helium regulator then retested three times and observed passing results before completing pm service.All safety, functionality, and calibration checks were performed and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).
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