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 cable.The technician replaced the cable to resolve the reported failure.A burned through cable could be identified as root cause for the reported issue however it could not be determined why the cable got burned through.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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