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.A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit and noted that the batteries were fully charged and no faults were found in the iabp log files that would indicate problems with the batteries or charging of the iabp unit.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.(b)(6).
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