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Model Number N/A |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/09/2021 |
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.However, the fse found a broken fiber optic connector and no signs of "optical sensor error" present in fault logs or main therapy screen.To fix the issue, the fse replaced the fiber optic assembly, and performed all functional and safety checks to meet factory specifications.Unit passed all 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 routine service, the cs300 intra-aortic balloon pump (iabp) had an optical sensor error.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 routine service, the cs300 intra-aortic balloon pump (iabp) had an optical sensor error.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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