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 Consequences Or Impact To Patient (2199)
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Event Date 09/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit, and observed a bent ground pin on the ac power cord plug.The stm replaced the ac power cord, and the power supply.In addition, the stm also replaced the safety disk as it was due to be replaced.Subsequently, the stm completed all safety, functionality, and calibration checks, and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.The full name is (b)(6).
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Event Description
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) did not recognize that it was plugged in.There was no patient harm, and no adverse event was reported.
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Event Description
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) did not recognize that it was plugged in.There was no patient harm and no adverse event was reported.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, h2, h6(evaluation method codes), h10.
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