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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Edwards has received several confirmed complaints on the swan-ganz continuous cardiac output (cco) catheter products in which cardiac output measurements were unavailable and the following fault message was displayed in the vigilance monitors:"fault. cco catheter verification. use bolus mode."(instead of continuous output mode).