There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa and 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 device.He could not confirm the reported smoke.However, as soon as the unit was started, the mains supply was tripped.The technician traced the failure back to a defective compressor.The smoke could be generated from the interaction of the coolant and the chemicals used for the routine cleaning of the device.The root cause could be a hole in the evaporator causing leak of coolant and water entering the refrigeration cycle and thus damaging the compressor.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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