There was no known 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) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Customer reported that the device was cleaned according to the instruction for use.Reportedly, the units are usually placed inside the operating rooms during use with the fans are usually positioned correctly as described in the instruction for use.The device will be deep disinfected at the manufacturer site in order to solve the reported issue.No further information has been made available.Thus, no root cause could be determined.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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