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 investigate and the reported failure was duplicated.To resolve the issue, the stm replaced the main board.In addition, the stm also completed full preventative maintenance (pm) on the unit and ensured that all calibration, functional and safety tests were passed per factory specifications.The iabp was then returned to the customer and cleared for clinical service.Full name of initial reporter: (b)(6).
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