DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported "power up" issue.The fse determined the start up time for the iabp was consistent with factory specifications, completed a pm with full 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.
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Event Description
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It was reported that during a routine check, the cardiosave intra-aortic balloon pump (iabp) had an issue with the system power up.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that during a routine check, the cardiosave intra-aortic balloon pump (iabp) had an issue with the system power up.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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