There was no patient involvement.Contact telephone number:(b)(6).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) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative confirmed the reported issue and identified a faulty compressor.The customer decided not to proceed with a repair.The device was isolated and the customer plans to scrap the device due to age.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Device was scrapped.
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