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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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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) 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.A getinge field service engineer (fse) was dispatched to the customer's site.The fse evaluated the iabp unit and found electrical test code failure error #53, and replaced the shuttle transducer.The fse performed all calibration, functional and safety tests on iabp, which passed.The iabp was returned to the customer and cleared for clinical use.The full initial reporter named is (b)(6).The full event site name is (b)(6) medical center.
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) had an electrical test fails code 53.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and there was no adverse event reported.
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Manufacturer Narrative
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) had an electrical test fails code 53.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and there was no adverse event reported.
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Search Alerts/Recalls
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