Catalog Number 0998-00-0800-53 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/08/2017 |
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 the company standard operating procedure since the device manufacture date is greater than one year from the event date.The service territory manager (stm) arrived on site and found the iabp working with a trainer and fiber optic balloon.When the stm went into diagnostics he found that the iabp failed the fiber optic functional test with a fiber optic tester.The stm the replaced the fiber optic assembly.The iabp then passed all tests.The iabp passed all functional and safety tests per factory specifications, returned to the customer and cleared for clinical use.
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Event Description
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The customer stated that while in use on a patient the fiber optic was not working.The cardiosave intra aortic balloon (iabp) was swapped out to continue therapy.No patient injury, death or adverse event reported.
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Search Alerts/Recalls
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