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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It was determined that 20 heartstart mrx defibrillator/monitors were affected by the same organic contamination clogging the 9 um filter in the zero line of the etco2 module. this issue may expose a patient to a hazardous situation because: -a capnogram is not displayed and that may result in unrecognized intubation/ventilation issues -co2/respiratory rate monitoring is unavailable -etco2 will not be displayed necessitating that the user rely on other parameters to adjust ventilation rate and depth.