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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Due to a pressure increase after the cylinder switch-over there are 2 possible issues identified:1. the cylinder status icon can change and erroneously indicate remaining gas in an empty no(nitric oxide) gas cylinder. 2. the alarm "no cylinder 1 missing (or empty)" or "no cylinder 2 missing (or empty)" can be deactivated. if the empty no cylinder is not replaced both no cylinders can run empty and cause a stop in no delivery. there have been no reports of patient injury as a result of this issue.