The event occurred in the us.It was reported that a patient was transported from crouse hospital in syracuse, new york to university of rochester.The rotaflow console was plugged into two different ambulances and then showed a battery alarm and then turned off.They were able to hand crank the disposable until the rotaflow console could be turned back on.They eventually used a ups battery backup to plug in the rotaflow to successfully transfer the patient back to rochester.No harm to any person has been reported.The getinge sales and service unit (ssu) confirmed on 2022-06-17 that no getinge service has been performed on the affected rotaflow console.The hospital performed their own maintenance on the device and could reproduce the reported failure.It was found out that the circuit breaker in the ambulance was off which led to reported failure.Therefore the most probable root cause could be determined as a user error.Based on the investigation results the reported failure "shut down during transport / battery alarm" could be confirmed but no product related malfunction.The review of the non-conformities was performed on 2022-06-01 during the period of 2011-10-01 to 2022-06-01 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 rotaflow console in question was produced in 2011-10-01.In order to avoid reoccurrence of the reported failure "battery alarm", the sales and service unit (ssu) will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | v15.Chapter 3.3.4.Check battery capacity every 6 months, at the latest.The battery must be replaced by the authorized technical service every 2 years, at the latest.The battery must be replaced sooner if it cannot be fully charged within 8.5 hours or if the system cannot be operated with the fully charged battery.Chapter 5.6.1.Before starting the application, check the points listed in "check before every use".Before each use, ensure that the batteries are fully charged.If the battery capacity is low an acoustic signal sounds on the device.In order to avoid reoccurrence of the reported failure "shut down during transport", the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | 15.Chapter 2.1.4 intended use environment the rotaflow system is intended for use within clinical institutions.The rotaflow is not intended for transport outside of the hospital.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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