There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to the stirrer, which was found to not start when the unit was powered on.Replacing the distribution board and loosening the pump motor fixings did not resolve the issue.It was determined that the stirrer motor was faulty and a new one was ordered.The service representative returned to the facility at a later date to install the new motor.Functional testing did not identify further issues and the unit was returned to service.The replaced stirrer motor was requested for return to livanova (b)(4) for further investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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