The dispatched dräger fse examined the device, could confirm the reported behavior and narrow down the root cause to a problem with the ventilator motor.The device was tested after replacement of the motor, found full functional again and could be returned to use.The error codes found in the log file indicate fluctuations of the motor speed.The device is equipped with a piston ventilator which is driven by a stepper motor.The number of rotations forth and back is proportional to the piston hub and to the volume that will be shifted (tidal volume).The motor speed is being monitored continuously; speed fluctuations result in a deviation between measured and expected piston position.To prevent from damages to the ventilator unit the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.No patient consequences have reportedly occurred.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component which is a wear-and-tear part and has lasted longer than the expected life time.The repair exchange has fully solved the device problem.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
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