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)(6).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 a defective stirrer motor.The technician replaced the motor to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The defective stirrer motor was returned 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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The affected parts has been requested back to the manufacturer site for a detailed investigation.Results revealed that the stirrer motor had defective electronics.Furthermore, in accordance with the replacement conducted on site, investigation results confirmed also the involvement of the distributor board.The protective resistors r1 and r2 were high-impedance and two sockets were found to be defective.
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