It was reported that the hl 20 pump displayed the error message "error head" during a routine inspection.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on 2023-12-14.The optical tacho board was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The defective tacho board was not available for further investigation.However the failure can be linked to the following most possible root causes according to the hl 20 risk management file: (total) fail of device because of: defective tacho.The review of the non-conformities has been performed on 2023-12-15 for the period of 2015-12-09 to 2023-10-18.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 are unlikely.The device was manufactured on 2015-12-09.Based on the results the reported failure "error message error head" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.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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