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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Manufacturer has received reports of gas regulators being incorrectly set causing the device to initiate a 'no pressure too high' alarm. this problem was evaluated by the regulator manufacturer and the root cause was a production issue. potential incorrect setting of a regulator resulting in a 'no pressure too high' alarm is not regarded a patient risk.