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
Restricted Flow rate (1248)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to reproduce the reported issue.The fse disassembled the safety disk to confirm the internal condition and that there was no blood or moisture in the internal pipeline and no air leakage.The fse turned the unit on and confirmed that the power conversion, battery charging and discharging, and trigger were all normal, 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.
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Event Description
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It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) gave iab catheter restriction message.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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