Model Number N/A |
Device Problem
Power Problem (3010)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/31/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The stm found the console was not completely seated in the cart.The stm reseated the console in the cart and all led lights illuminated, and battery leds were blinking.The stm completed all safety, functionality, and calibration checks, and all tests passed to factory specifications.The iabp released to the customer but has not been cleared for clinical use due to it being over due for preventative maintenance (pm).Pm has been scheduled.
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Event Description
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It was reported that before use with a patient, the cardiosave intra-aortic balloon pump (iabp) had a power switch failure.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) completed a pm with full calibration.The iabp passed all functional and safety tests per factory specifications.Returned to customer and was cleared for clinical use.
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Event Description
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It was reported that before use with a patient, the cardiosave intra-aortic balloon pump (iabp) had a power switch failure.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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