The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.The getinge fse that encountered the issue removed the muffler, and while removing the muffler the threads on the pressure reservoir got damaged.After replacing the reservoir and the muffler, the fse completed the pm and tested the iabp unit, which the iabp worked to specifications.The iabp was then released to the customer and cleared for clinical service.(b)(6).
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It was reported that during a preventive maintenance (pm) of the cardiosave intra-aortic balloon pump (iabp), the getinge field service engineer (fse) discovered a crack in one of the internal filters (the muffler was cracked off).There was no patient involvement, and no adverse event reported.
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