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 evaluate the iabp unit.The stm confirmed the issue.The stm found the vacuum high and k6, k6a,, k7 and k8 leak test fails.The stm performed a 5000 hour rebuild of the compressor and replaced the drive manifold.The stm then 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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