Initially the report was submitted on may 25, 2018.Due to an incorrect e-mail it was not submitted.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).Recall number: 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).Through follow-up communication with the customer, livanova (b)(4) learned that the device was cleaned according to the instructions for use (ifu).It was further reported that the device was placed inside the operation room during use approximately 1 to 1.5 meters away from the operation table, with the fan directed towards the vent.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.Device not returned.
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