Model Number N/A |
Device Problem
Inability to Auto-Fill (1044)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/05/2017 |
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 company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported "autofill failure alarms" issue with a trainer and catheter connected.The fse performed all functional and safety checks to meet factory specifications, and the iabp was then released to the customer for return to clinical service.(b)(6).
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Event Description
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The customer reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had multiple autofill issues.No patient harm or serious injury was reported and there was no adverse event reported.
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Event Description
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The customer reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had multiple autofill issues.No patient harm or serious injury was reported and there was no adverse event reported.
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Search Alerts/Recalls
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