Model Number N/A |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A getinge field service engineer (fse) was dispatched to evaluate the iabp and was unable to reproduce the reported "gas loss alarm" issue.The fse performed full calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per 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 the cardiosave intra-aortic balloon pump (iabp) had a gas loss alarm.Biomed checked unit with no 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 the cardiosave intra-aortic balloon pump (iabp) had a gas loss alarm.Biomed checked unit with no 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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Search Alerts/Recalls
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