Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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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 co2 for the patient. this leakage is not detected during the ventilator operational readiness check.