DATASCOPE CORP. - MAHWAH CARDIOSAVE RESCUE DOMESTIC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-83 |
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 04/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The full name of the event site was shortened due to field character limit; the full name is (b)(6).Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to reproduce the reported issue.To fix the issue, the fse replaced the removable power supply and 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.
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Event Description
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It was reported that during routine check, the cardiosave intra-aortic balloon pump (iabp) would not charge.There was no patient involvement, and no adverse event reported.
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