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 manufacturing defect that occurred for certain inserts no electrolyte will be present under the new membrane if a membrane changer with such an insert was used to change the membrane and electrolyte. the pco2 performance of a sensor without electrolyte will be deteriorated. during a subsequent use built-in sensor diagnostics in most cases will trigger appropriate alarms/messages and replace pco2 readings by "----" or mark them to be unstable or questionable.