Health Canada — Medical Devices · Canada · 2016-06-16 · Type II
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Reported risk: During the course of routine internal testing, the firm detected isolated episodes of leakage at the check valve (one way valve of the inspiration branch) of the disposable pediatric ventilation hose of Oxylog 3000 system and Oxylog plus, model 5704964. Affected circuits with this fault were potentially distributed to customers. All other ventilation circuits for the Oxylog family of devices are not affected. Leakage at the check valve can result in patient's exhaled gas entering into the breathing circuit, which could lead to the rebreathing of the same exhaled gas with reduced oxygen concentration/elevated CO 2 for the patient. This leakage is not detected during the ventilator operational readiness check.
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