The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge service territory manager (stm) was dispatched to investigate.The stm performed all manifold leak tests, the patient interface module (pim) test, and verified calibration of the iabp unit.The iabp was ran with a trainer and test balloon for 45 minutes without issue.The stm was unable to reproduce the customer's reported issue.The stm then performed all calibration, functional and safety tests per factory specifications and the iabp was returned to the customer and cleared for clinical service.
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