DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-52 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/27/2021 |
Event Type
malfunction
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Event Description
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It was reported that during patient use the cardiosave intra-aortic balloon pump (iabp) was showing "gas loss in iab circuit", the customer advised that when taking the patient to a ct scan they removed the unit from the hospital cart, when the unit was removed from the cart they confirmed that the helium tank was full.The pressure of the helium cylinder dropped to half.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp unit but was unable to reproduce the reported issue of "gas loss alarm".He reviewed the logs, ran the unit on rescue mode with the balloon for testing, and also passed the all manifold test.He then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per 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.(b)(6).
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