It was reported that the hl20 device displayed the error message: "runaway." no harm to any person was reported.A getinge field service technician was onsite and investigated the unit in question.It was found that the tacho strobe foil on the otical tacho board was damaged and needs to be replaced.Thus the reported failure could be confirmed.Device was manufactured in 2008-04-25.The review of the non-conformities during the period of 2008-04-25 to 2022-11-23 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.An investigation of the tacho strobe foil is not possible as it is always damaged during removing of it.The most probable root cause could be determined as a mechanical damage of the marks on the tacho strobe foil.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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