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).This event was initially considered to be non-reportable.However, after additional evaluation, livanova (b)(4) has decided to reclassify this event as reportable.This report is being filed as part of a retrospective review conducted in response to this new decision.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The unit was returned to livanova (b)(4) for further investigation.As a result of the investigation a hole was found in the cooling coil causing the reported issue.The unit was scrapped upon completion of the investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
|