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 06/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: during an in service by a getinge clinical rep he stated that the pump would not charge the batteries after he put the console back into the cart.Once he unplugged the pump from the outlet and back in again the batteries began to charge again, could not duplicate the issue with the pump.The fse replaced the power management board and batteries as a precaution, and 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 training class the cardiosave intra-aortic balloon pump (iabp) batteries would not charge.There was no patient involvement, and no adverse event reported.
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