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 Run on Battery (1466)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 latch optical sensor, and then performed a full preventive maintenance (pm) with 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.
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Event Description
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It was reported that during a routine check performed by the customer, the cardiosave intra-aortic balloon pump (iabp) would not switch from hybrid to rescue mode when released.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 performed by the customer, the cardiosave intra-aortic balloon pump (iabp) would not switch from hybrid to rescue mode when released.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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