There was no known 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) 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).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.
|
The follow up report 9611109 -2020 -00369 was previously sent with empty by mistake.Please find below the details: through follow up communication for other event from the same hospital and for the same unit, (b)(4) learned that the device was cleaned regularly per the ifu, placed inside of the operation theater during use, with the fan facing away from the patient in direction of an exhaust fan in the wall.The device was kept in a housing with negative pressure in relation to the pressure in the or.The estimated distance between the surgery field and the device was 3 meters.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|