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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Avea ventilators can over-time develop a pressure transducer failure where the ventilator activates a false extended high ppeak or circuit occlusion alarm. this will cause safety value to immediately open and stop device from ventilating. (193 devices/154 spare parts affected).