The ventilator was investigated by field service engineer (fse).It was not possible to duplicate the reported event.No parts were replaced.The ventilator passed all safety and functional tests and was cleared for clinical use.Provided ventilator logs were reviewed.In the event log there are alarms for airway pressure high and expiratory minute volume low which were generated sporadically during the ventilation.However, the frequency of these alarms increased the last 10-12 minutes of the ventilation.The generated alarms for airway pressure high are an indication of high resistance in the patient circuit.When the alarm occurs, inspiration goes over to expiration and this will restrict the volume delivery to the patient.If the expired volume in the shortened breath falls below the set lower minute volume alarm limit, the expiratory minute volume low alarm will be generated.The trend log shows that the ventilator continuously delivered pressure and flow during the ventilation.During the last 10-12 minutes of ventilation the respiratory rate, inspiratory minute volume and leakage increased and the expiratory minute volume decreased which indicates a leakage.There are no technical error codes that indicate any technical issues with the ventilator.Pre-use checks prior and after the reported event were passed without remarks.The conclusion is that there are no indications of ventilator malfunction.The alarm generation indicates that the ventilation may have been insufficient.The logs indicate that a leakage occurred during the last 10-12 minutes of ventilation.The cause of the leakage has not been determined.
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