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
Failure to Charge (1085)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2023 |
Event Type
malfunction
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Event Description
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It was reported that during routine check, the cardiosave intra-aortic balloon pump (iabp) unit will not charge batteries.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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Event Description
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N/a.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and the fse found that the cardiosave would run normally on ac power but would not charge the batteries, which were now fully discharged.The fse replaced the power management board which resolved the issue.The fse completed a full pm service, all tests passed to factory specifications.Returned to the customer and released for clinical use.The following investigation was performed by a technician of the maquet failure analysis and testing dept.(fat) wayne, nj: the failure analysis and testing dept.Received with a reported unit failure of the batteries not charging in the iabp.The fat performed a visual inspection and found the part to have a damaged q27 component.Please see attachment.Due to the risk associated with this damage and the cardiosave test fixture, fat cannot install and test this board.This revision is obsolete and no longer able to be tested by a supplier.Retaining the part in the failure analysis and testing department per procedure.
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