Model Number 801041 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/07/2018 |
Event Type
malfunction
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Event Description
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After use of the device for a cardiopulmonary bypass (cpb) procedure, an 'underspeed' error message was displayed.There were no reported adverse consequences to the patient.
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Manufacturer Narrative
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Evaluation is in progress, but not yet concluded.
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Manufacturer Narrative
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During laboratory evaluation, the product surveillance technician (pst) was unable to duplicate the reported complaint.He observed the pump to function as intended during optimal occlusion settings.Only when the pump was occluded 80 clicks past optimal occlusion did an 'underspeed" error occur.
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Manufacturer Narrative
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The reported complaint could not be confirmed.The service repair technician (srt) was unable to duplicate the reported complaint.No parts will be replaced as the unit operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Search Alerts/Recalls
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