Based on the analysis of the device logfile, it was found that indeed no vent fail occurred during use.There were problems with the ventilator motor found during the self-test of the device, so prior to use.If known before, the case would not have been deemed reportable.In general, the motor speed is being monitored continuously; speed fluctuations caused e.G.By an abraded collector disc will result in a deviation between measured and expected piston position.To prevent from damages during use, 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.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component and detected the issue during self-test prior to use; no patient consequences have been reported.The motor has already been replaced, no further actions were deemed necessary.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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