The initial failure description was that the rotaflow " battery turned off during patient treatment".A getinge service technician was on site on 2021-09-27 to repair the affected rotaflow console (rfc) (serial(b)(6)).The technician started that rotaflow in the battery mode and the voltage of the battery was 25.8v.Therefore, the battery was within tolerance.Therefore, the technician could not confirm the reported failure.Neverless, the technician replaced the batterypack ni-cd 24v 132wh (material#701017188) as the rotaflow was due for preventative maintenance in novemeber 2021.After the replacement the device is working as intended.Based on these investigation results the reported failure could not be confirmed.However the failure mode " battery turned off during patient treatment" can be linked to the following most possible root causes according to our risk management file (dms# 2023689).Battery power failure e.G.: defect batteries, power supply board failure, software error, user forgot recharge, defect of charger unit.The product in question was produced in 2012-05-01.The review of the non-conformities has been performed on 2021-10-14 for the period of 2012-05-01 to 2021-09-16.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.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.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.
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