Patient information was not provided.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).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative was unable to confirm the reported issue.No traces of burned components were identified.However, during troubleshooting, the compressor did not turn on and made a clicking noise.The device is planned to be returned to livanova (b)(4) for investigation and repair.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.Device not returned.
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The involved unit was returned to livanova (b)(4) for investigation and repair.During evaluation, the reported issue was confirmed and the root cause was identified to be a hole in the evaporator of the device.Due to this damage, the starting capacitor was destroyed, leading to the reported smoke.Livanova (b)(4) has initiated corrective action for this type of issue.
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