Model Number 0998-00-0800-55 |
Device Problem
Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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).Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted upon completion of our investigation.No service requested.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had power failure.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Event Description
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It was reported that during routine inspection, the cardiosave intra-aortic balloon pump (iabp) unit had power failure.There was no patient involvement.
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Event Description
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N/a.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and was able to confirm the reported issue.The fse replaced the power management board to resolve the issue.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp was then released to the customer and cleared for clinical service.
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Search Alerts/Recalls
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