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 03/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that, the cardiosave intra-aortic balloon pump (iabp) gas leak error.There was no harm reported.
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Manufacturer Narrative
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Updated data: b4,g3,g6,h2,h10,h11.Corrected data: e3.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that they were unable to reproduce the issue.The fse found no major faults in the logs.The fse completed preventative maintenance.The unit passed all functional and safety tests and was returned to customer and was cleared for use.
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