A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.However, the fse replaced the coil cable with a new cable.Also, the fse noticed a crack in the top cover, possible a liquid intrusion point, so it was replaced.The fse performed all calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory 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 use on a patient, the cardiosave intra-aortic balloon pump (iabp) alarmed, turned off and then turned back on.No patient harm, serious injury or adverse event was reported.
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