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 06/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: (10/213) during a repair service, the getinge field service engineer (fse) found that the system would not charge batteries when plugged into ac power.The main ac and charge indicators illuminated but the bay would only light for a few seconds and go off, and no charging.To fix the issue, the fse replaced the power management board and tested the system ok, the batteries are now charging.The fse 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.The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).
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Event Description
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It was reported that during a repair the getinge field service engineer (fse), found that the cardiosave intra-aortic balloon pump (iabp) would not charge the batteries when plugged into ac power.There was no patient involvement, and no adverse event reported.
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