The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed 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 dispatch to evaluate the iabp.The stm was unable to reproduce the reported issue.The stm performed all leak tests, tested the compressor and verified the iabp was in calibration.The stm additionally tested the iabp with a trainer and test balloon without issues.All functional and safety tests were performed and passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.
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