It was reported that the rotaflow "battery is not holding a charge" during patient treatment.The failure occurred during patient treatment.The device was plugged back into the outlet.No patient harm occurred.A getinge service technician was on site on 2022-03-10 to repair the affected rotaflow (serial (b)(6)).The last replacement of the battery was in march 2020.When the device was used in the battery mode the battery showed a voltage of 12v and then shutting down immediately.The technician replaced the battery pack with fuse (material#70101.7188).After the replacement the device is working as intended.The root cause could be determined as due battery replacement.Based on the investigation results the reported failure "battery is not holding a charge" could be confirmed.The product in question was produced in 2012-11-01.The review of the non-conformities has been performed on 2022-03-31 for the period of 2012-11-01 to 2022-03-08.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.In order to avoid reoccurrence of the reported failure, 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.If the voltage drops to 20 v, there is only power left for a very short time.At a voltage of 19 v the system switches off automatically.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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