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Model Number N/A |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/08/2021 |
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 was unable to reproduce the reported issue.As a precautionary measure, the fse replaced the 9v batteries, and completed a pm with 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 during a routine check, the cs300 intra-aortic balloon pump (iabp) powered down on its own, while plugged in.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 a routine check, the cs300 intra-aortic balloon pump (iabp) powered down on its own, while plugged in.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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