Model Number N/A |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/16/2018 |
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 reported by a getinge field service engineer (fse), that the fse contacted the customer and they reported that they were able to remedy this fault on their own, and the iabp unit has been placed back into clinical use.
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Event Description
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The customer reported that after they were running through functional tests on the cs300 intra-aortic balloon pump (iabp) due to a safety disk replacement, during the safety disk leak test the iabp unit would not recognize the safety disk.The customer tried other test and the iabp unit would not respond.The unit recently had the field actions applied by (b)(4) technician representative.There was no patient involvement, and there was no adverse event reported.
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Manufacturer Narrative
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The customer stated that after replacing batteries this unit became fully functional.
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Event Description
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The customer reported that after they were running through functional tests on the cs300 intra-aortic balloon pump (iabp) due to a safety disk replacement, during the safety disk leak test the iabp unit would not recognize the safety disk.The customer tried other test and the iabp unit would not respond.The unit recently had the field actions applied by uhs technician representative.There was no patient involvement, and there was no adverse event reported.
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Search Alerts/Recalls
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