No service was requested and no parts were replaced.No ventilator logs were provided.Investigation consists of an evaluation of information received from the user facility the user facility explained that the ventilator passed pre-use check prior start of ventilation.During ventilation, alarms for low expiratory minute volume and technical error in expiratory cassette were generated.The ventilator was replaced and investigated.It was noted during the user facility investigation that the cleaning/disinfection procedures of the expiratory cassette had not been carried out in accordance with the user facility guidelines.In what way was not further communicated.After the expiratory cassette was cleaned according to user facility guidelines, it worked according to specification.The cleaning and maintenance user¿s manual of the ventilator clearly states the procedures for cleaning, disinfection and sterilization of the expiratory cassette.It has been reported that the user now is aware of the correct procedures.The alarms for low expiratory minute volume may be an indication of leakage leading to a loss of volume to the patient, but can also be a measuring error in the inappropriately cleaned expiratory cassette.The alarm technical error in expiratory cassette will not affect on-going ventilation, but the measured and monitored values may not be correct.The root cause of the reported delivered tidal volume lower than set level has not been conclusively determined but was most likely due to leakage.There are no indications of ventilator malfunction.The expiratory cassette is a measuring device in the expiratory section of the patient unit and will not affect ventilation.H3 other text : 4117.
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