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Model Number N/A |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp and confirmed the issue on site.The fse found the leak in the back of the unit where the o-ring was broken and replaced it.Subsequently, the fse completed scheduled preventative maintenance (pm) and completed all safety, functionality, and calibration checks.All tests passed to factory specifications and the iabp unit was cleared for clinical use and released to the customer.
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Event Description
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It was reported that during an internal training performed by customer, the cardiosave rescue intra aortic balloon pump (iabp) experienced a helium leak.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 an internal training performed by customer, the cardiosave rescue intra aortic balloon pump (iabp) experienced a helium leak.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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