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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Avea ventilators may experience the underreporting of tidal volume if used in conjunction with the neonatal hotwire flow sensor carefusion part number 16465. this error is due to the barometric pressure sensor compensation. clinically significant changes in barometric pressure are generally seen at altitudes greater than 5000 feet above sea level (asl). single patient use varflex sensors are not affected by this corrective action and will compensate for changes to atmospheric barometric pressure. the adult and pediatric patient setting are not affected by this issue.