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Model Number N/A |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.It was found in the fse's evaluation that as per the fault logs, there were autofill failure, augmentation, and check iab alarms.Since the fse performed a field action that required a full preventive maintenance (pm), the fse tested all aspects of the iabp and found the iabp to be working to 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 by a getinge field service engineer (fse) that when performing a field action, he found a red tag on the cs300 intra-aortic balloon pump (iabp) that said "malfunction".The fse asked the customer's biomedical engineer about the red tag, and it was explained that they didn't know what happened, only that during use on a patient, the cs300 iabp had a malfunction, and the iabp was swapped and all went well.No patient harm, serious injury or adverse event was reported.
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Search Alerts/Recalls
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