It was reported that the hcu 30 not turn on during a preparation for the emergency surgery.The start of the surgery has been delayed.A getinge field service technician (fst) was sent for investigation on 2021-03-05.The fst confirmed the failure and replaced the mcp00703837 # control board , type 2 pc1891 (material#701034530), the current probe (material#701034527) and the mcp00703831 # power supply board, type 2 (material#701034529 ).The device passed all function tests and has been put back in use.A similar failure was investigated at getinge life cycle engineering on 2017-10-11 as part of a previous complaint.The most probable root cause is a high contact resistance which was probably caused by corrosion or a bad crimp connection.The device was manufactured on 2010-10-28.The review of the non-conformities has been performed on 2021-02-22 for the period of 2010-10-28 to 2020-12-31.It 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 was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.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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