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: k191402).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in montpellier, (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The technician in charge of the service activity traced the failure back to a defective cooling unit.The device will not be repaired.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|