The production device history record (dhr) for this intra-aortic balloon pump (iabp) is 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 field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue, the fse replaced the ecg input cable assembly, and performed all functional and safety checks to meet factory specifications.The fse also completed a full preventive maintenance (pm) and checkout checklist.As part of the pm the fse replaced the safety disk due to use hours and the batteries from the customer stock.The iabp was then released to the customer and cleared for clinical service.
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