There was no patient involvement.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).Initially, it was believed that only one device was effected by this event.However, multiple heater-cooler cables were returned to the original equipment manufacturer for further investigation.During the evaluation, damage to the fuse point of the plug indicative of electrical charring was identified on an additional cord.Based on this information, it was determined that 2 serial numbers were affected by the reported issue.The device current is insufficient to cause the damage discovered.A measurement of the conductor resistance showed no deviation from the specification.It was determined that the cause of the damage was most likely a faulty socket with an increased contact resistance.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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