Model Number 0998-00-0800-53 |
Device Problems
Electrical /Electronic Property Problem (1198); Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information has been requested, and we will report accordingly if it becomes available.
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Event Description
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It was reported that during start-up, the cardiosave intra-aortic balloon pump (iabp) had an electrical test failure 13.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that during start-up, the cardiosave intra-aortic balloon pump (iabp) had an electrical test failure 13.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp unit and replaced the power management board and executive processor board to fix the issue.The safety disk and tidal volume disk were also replaced.The fse could not get the iabp to replicate the reported issue after that, 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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Search Alerts/Recalls
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