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 10/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and determined the leak was caused due to user error.Specifically, the fse found a foreign object between the helium tank mating surface and the rubber seal.Once the obstruction was removed the unit passed the helium leak test.The fse performed a full pm with calibration, 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.Additionally, it was stated that a full tank was installed in the evening and was drained to empty by the following morning.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 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: d5, g1 (contact person ¿ mfg site).
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Event Description
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N/a.
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Search Alerts/Recalls
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