DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-53 |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate this unit and reported that performed and passed all fiber optic balloon tests without errors.The fse stated that no faults were found in the iabp's logs.The fse performed and passed all functional and safety tests to factory specifications.The iabp was released to the customer and cleared for clinical service.A supplemental report will be submitted when the investigation is completed.
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Event Description
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It was reported that before use, the cardiosave intra-aortic balloon pump (iabp) displayed "error unable to use fiber optic".There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields; b4, g3, g6, g7, h2, h6, h10.
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Event Description
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N/a.
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Search Alerts/Recalls
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