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 03/06/2024 |
Event Type
malfunction
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Event Description
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It was reported under unknown circumstances, the cardiosave intra-aortic balloon pump (iabp) had gas loss in circuit.There was no patient involvement.
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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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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp but was unable to reproduce the reported issue and during testing observed expired safety disk.The fse replaced the safety disk and performed all manifold leak test, passed to specifications.Unit passed all functional and safety tests per factory specifications, returned to customer.
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Event Description
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N/a.
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Search Alerts/Recalls
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