DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-45 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.E1 event site name was shortened due to character limitations.The complete name is the (b)(6) hospital.E1.Event site telephone was shortened due to character limitations.The complete number is: (b)(6).
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Event Description
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It was reported the cardiosave intra-aortic balloon pump (iabp) had iab loop air leakage.The unit was immediately switched for another to continue therapy.There was no harm reported.
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Manufacturer Narrative
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Updated data: b4, e2, e3, g2, g3, g6, h2, h10, h11.
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Event Description
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It was reported that during use, the cardiosave intra-aortic balloon pump (iabp) had iab loop air leakage.The unit was immediately switched for another to continue therapy.There was no harm reported.
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Search Alerts/Recalls
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