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
Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/05/2021 |
Event Type
malfunction
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Event Description
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It was reported that during use on a patient the cardiosave intra-aortic balloon pump (iabp) was alarming for 2 hours "gas loss", but continued to support the patient.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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Additional information is being requested in regards to whether or not the customer has requested for getinge to service the iabp unit involved.A supplemental report will be submitted when additional information is provided.(b)(6).Device not returned to manufacturer.
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Event Description
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N/a.
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Manufacturer Narrative
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At this time, the customer has not requested getinge to evaluate the iabp.Additional information was requested with regard to the repair and status of the iabp; however, despite our best efforts, no repair information and no status of the iabp has been received.If any pertinent information is received in the future, a supplemental report will be submitted.
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Search Alerts/Recalls
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