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 12/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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During a preventative maintenance (pm) service, the getinge field service engineer (fse) discovered that there was a defective battery, to fix the issue the fse replaced the battery due to it having a charging issue.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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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), discovered that the cardiosave intra-aortic balloon pump (iabp) had a defective battery that will not charge on either bay.There was no patient involvement, and no adverse event reported.
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Event Description
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N/a.
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Search Alerts/Recalls
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