Model Number 0998-00-0800-55 |
Device Problem
Component Incompatible (1108)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2023 |
Event Type
malfunction
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had an auto purge failure.The customer changed the helium cylinder without resolving the failure.
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Manufacturer Narrative
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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 before use, the cardiosave intra-aortic balloon pump (iabp) had an auto purge failure.The customer changed the helium cylinder without resolving the failure.There was no patient involvement.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue, the fse replaced helium reservoir, pneumatic module assay 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 for cleared for clinical service.
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Search Alerts/Recalls
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