The investigation was performed based on the log analysis whereby the reported ventilator failure could be confirmed.No indications for a device malfunction being root cause for the ventilator failure were found.The reported symptom was caused by an overpressure at the patient end of the circuit leading to a pressure peak.Most likely, the patient was coughing against the ventilator at that time explaining the pressure peak.To prevent from damages, 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.The device reacted as specified for the detected situation.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.H3 other text : on-going.
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