It was reported that the cardiohelp is going into emergency mode unprompted.The field service technician was unable to reproduce the failure and was sending the device to the depot repair center for evaluation.A getinge field service technician (fst) of the depot center investigated the cardiohelp device on 2023-06-27/29.No part was replaced.The cardiohelp was tested for two weeks at 3200 rpm.The fst could not verify that the unit goes into emergency mode unprompted.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.(refer to service order (b)(4)).An exact root cause could not be determined, as the failure is not reproducible.According to the risk file v24 of the cardiohelp device the following root causes can lead to the reported failure: - communication to motion controller disturbed; - wrong speed; - wrong flow direction (tubes).The device history record (dhr) of the cardiohelp was reviewed on 2023-05-26.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the results the reported failure "going unprompted into emergency mode" could not be confirmed.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from 2022-05-19 till 2023-05-19) 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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