The log file of the affected device and provided information built the basis for the investigation.The logged entries indicate a faulty cable harness flow sensor.The cable harness flow sensor is necessary to measure the expiratory flow, which is used for control and monitoring of the ventilation.In case the measurements are adulterated, influence on the ventilation is likely and an exceedance of set alarm limits triggers corresponding visual and audible alarms (e.G.Leakage alarms).In addition, a ¿chattering¿ noise may be observed close to the expiratory valve.However, ventilation does not completely stop.The ifu states as a warning: "if a fault is detected in the medical device, its life-support functions may no longer be assured.Ventilation of the patient using an independent ventilation device must be started without delay, if necessary with peep and/or an increased inspiratory o2 concentration (e.G.With a manual resuscitator)." there were no patient consequences reported.It can be concluded that the device alarmed as specified in order to alert the user to detected deviations.The suspected cable harness flow sensor has been already replaced on site.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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