It was reported that the ventilators air gas module was contaminated with water and that internal leakage test failed.The service engineer found that the ventilators air gas module was defective and needed to be replaced.It was also reported that water had entered the ventilator from the hospital gas system.No part was returned for investigation.The evaluation of received device logs shows that the pre-use check internal leakage test failed with the reported message system volume too low as early as (b)(6) 2020, which will be used as the date of event.If the air gas module contains water, the patient may receive an amount of oxygen in the gas mixture that deviate from the expected.Flow and pressure may also deviate from the expected.Alarms will be activated if the failure occurs during ventilation.The most probable source of moisture/water into the air gas module is moist air from the hospital's external compressor, which in this case was confirmed in the service report.According to the user's manual, maximum levels of water (h2o < 7 g/m3) in the supplied gases to the ventilator must not be exceeded.
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