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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There have been nine complaints globally of the ventilator entering non-responsive state while connected to an external battery system which can cause a delay in treatment. this event can occur after the device is in a standby state only and does not occur during therapy. this only affects devices with astral service release 1.1 (sr1.1) software.