Model Number 0998-00-0800-53 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2022 |
Event Type
malfunction
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Event Description
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As part of preventive maintenance it was reported the cardiosave intra-aortic balloon pump (iabp) had an autobox failure.There was no patient involvement.
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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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As part of preventive maintenance it was reported the cardiosave intra-aortic balloon pump (iabp) had an out of box failure.There was no patient involvement.
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Manufacturer Narrative
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The getinge field service engineer (fse) that encountered the reported issue during the preventative maintenance (pm) replaced the safety disk to fix the issue and performed a full functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The pm was completed and the iabp was then released and cleared for clinical service.
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Search Alerts/Recalls
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