Model Number N/A |
Device Problems
Leak/Splash (1354); Gas/Air Leak (2946)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the unit and was able to reproduce the reported issue.The fse found that the helium leak was continuous, but not in the regulator.The fse resolved the helium leak by replacing the o-ring buna-n 1-008 n70.The fse then performed leak test, all functional and safety checks to meet 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 during a routine check, the cardiosave intra-aortic balloon pump (iabp) had a helium leak.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.
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Event Description
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It was reported that during a routine check, the cardiosave intra-aortic balloon pump (iabp) had a helium leak.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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