It was reported that the hcu 30 showed the error ¿1004-2 main heater temp.Sensor error¿.The getinge field and service technician (fst) has been sent for investigation, on (b)(6) 2021.The fst confirmed the failure.According to the service report #43608400, the fst has replaced the actuator 24v ac/dc 50/60hz (material #70103.4052) and cleaned the 3-way valve.All function tests passed.The device is back in clinical use.Therefore, the most probable root cause for the failure "1004-2" is a defective actuator 24v ac/dc 50/60hz (material #70103.4052).The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.Thus, the reported failure ¿error 1004-2¿ can be confirmed.The failure occurred during self-test.The hcu 30, which was used, was responsible for this complaint.The product in question was produced in (b)(6) 2013.The review of the non-conformities during the period of (b)(6) 2013 to (b)(6) 2021 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences can be excluded.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary´s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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