There was no patient involvement.Initial contact telephone number: (b)(6).The heater-cooler 16-02-80 is not distributed in the usa.However, it is similar to the 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 event occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and identified the root cause to be a faulty motor.The stirrer motor, processor board and distribution board were replaced to resolve the issue.Subsequent functional testing was completed without further issues and the unit was returned to service.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 issue is received, it will be provided in a supplemental report.Device not available for return.
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