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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Philips respironics has identified an issue where a non-conforming part (side panel) was utilized on the bipap a40 that affects the mechanical connection between the bipap a40 and the detachable battery module. the issue results in the inability to connect the bipap a40 device to the detachable battery module during setup before putting the ventilator into operation on a user.