Catalog Number 0998-00-3023-53 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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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) unit is not required to be reviewed per standard operating procedure (sop) since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to evaluate the iabp.The stm was able to reproduce the reported issue.The stm determined that the drive pressure transducer was defective.To fix the issue the stm replaced the drive pressure transducer, and performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.The full name of the event site is (b)(6).
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) displayed "electrical test fails code #52".It is unknown under which circumstance this event occurred.However, there was no patient involvement, thus no adverse event was reported.
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Search Alerts/Recalls
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