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 Date 09/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device : a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and discovered the back cover on the unit smashed in causing damage to the fill manifold causing the helium leak.The fse resolved the issue by replacing the fill manifold, rear handle, console cart release latch, and console cover.The fse performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.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 during a routine check, the cardiosave intra-aortic balloon pump (iabp) had a helium leak and draining the helium tank.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, g8, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person).
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Event Description
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N/a.
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Search Alerts/Recalls
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