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 replaced the fiber optic connector as a precautionary measure to prevent breaking.The stm tested the fiber optics to verify it was functioning after the repair.Subsequently, the stm completed pm service, all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released.(b)(6).
|