DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Power Problem (3010)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/21/2020 |
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.Service instructed biomed to reengage the console in the cart.This action started the battery charging and system was fully functional on ac.The fse performed all functional and safety checks to meet factory specifications.Unit passed all 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 prior to use, the cardiosave intra-aortic balloon pump (iabp) had no ac power and the battery depleted.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) had no ac power and the battery depleted.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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