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 (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The standard for a (b)(4) plug top and socket, which is used in (b)(4), is 13a (ampère) and heater cooler is rated 16a.This caused the heating which lead to burned plug top and alarm in the electrical panel of the building.A 16a socket will be used to solve the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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