As reported, neither logfiles nor further information were available - it was further reported that the device will remain out of use and be replaced with a new unit.Based on the available information, most likely an expiratory valve leakage led to the reported symptom.However, an expiratory valve leakage does not lead to a stop of ventilation.It was plausible that bigger leak flows caused deviations from desired tidal volume that were interpreted as stop of ventilation.In general, in case the device measures an expiratory flow of more than 15 ml during inspiration, an alarm message ¿ex port leakage¿ will be generated, as it was reported in the particular case.Automatic ventilation remains unaffected.The integrated pressure-, volume- and o2-monitoring of the fabius device ensures that visible and audible alarms will be generated if the delivered tidal volume is less then set/expected.Based on the experience from other cases, this symptom most likely is related to a leakage in the mechanical section of the peep valve inside the cosy.In the framework of continuous product improvement, a design change of the peep valve has already been started.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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