The device in question was investigated by a getinge field service technician.The technician checked the device and replaced according to the part removed grid the rf power supply board (701011675) was replaced.The device was tested after the replacement.The instructions for use rotaflow| 4.2 | en | 13 was reviewed on 2021-02-03 with the following outcome: in chapter 2.2 general safety instructions 2.2.2 position of use and operation, and positioning it is described as follows: - only operate the rotaflow system within the specific technical and ambient conditions (¿ "ambient conditions", page 76).Ambient temperatures outside of the specified conditions can disrupt the sensors' measurements.This may result in incorrect measurements, which may cause incorrect values be displayed and trigger alarms.There must be no risk of condensation.Condensation may occur when the device is taken from a cold environment into a warm room.- make sure that the ventilation openings are not obstructed and the rotaflow system is not covered.There is a risk that the rotaflow system will overheat.Ensure a minimum distance of 50 cm to other devices, objects, or the wall.The rotaflow risk analysis version v06 (dms# 2023689) chapter h1.1.1.10 was reviewed on 2021-02-03 with the following outcome: the most possible causes for the reported failure "b temp error" could be determined as: over-temperature condition in the device, e.G.: * increased heat generation due to short circuits * defect battery * heat accumulation * heat generation due to motor blockage * device used out of specification * charging of battery a device history review (dhr) was performed and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.The reported failure "b temp error" could be confirmed.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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