A.1.-a.5.There was no patient involvement.G.5.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).H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in stuttgart, germany.A livanova field service representative inspected the device, however there was no error message displayed, therefore the reported issue was not reproduced.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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