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 dispatched to evaluate the iabp and was unable to reproduce the reported issue.However the stm was able to verify the alarms in the iabp¿s diagnostic error log and while testing the iabp, observed dirty o-rings on the back side of the safety disk.To address the issue the stm cleaned the safety disk o-rings and 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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