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
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) drained two helium tanks.There was no patient involvement.
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Event Description
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N/a.
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Manufacturer Narrative
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had a issue of unit drained 2 helium tanks.There was no patient involvement, and no adverse event was reported.A getinge field service engineer evaluated the unit and found unit drained 2 helium tanks- replaced high pressure helium regulator, screw set, bushing regulator to resolve issue.Preformed unit checkout.Unit passed all functional and safety testes.
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Search Alerts/Recalls
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