DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate.The fse replaced the damaged power cord, and then performed iabp diagnostic tests.The unit passed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.(b)(6).
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Event Description
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It was reported that during a routine check, the power cord of the cardiosave intra-aortic balloon pump (iabp) was found damaged and exposed the internal wires.Notwithstanding, the power cord still worked.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 power cord of the cardiosave intra-aortic balloon pump (iabp) was found damaged and exposed the internal wires.Notwithstanding, the power cord still worked.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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