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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Patients have been inadequately ventilated because the dead space of the breathing circuit was not completely considered by the user when setting the ventilation parameters. the information for use (ifu) for the oxylog 3000 devices delivered from september 2008 contains additional warnings and cautions. a safety notice with the ifu amendment will be sent out to users who own affected oxylog 3000. no patient injury has been reported in relation to that dead space issue.