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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We have had one occurrence of a disconnection from the ventilator tubing which was not detected by the ventilator i.E. no alarms were triggered. this absence of alarms may occur with system version 1.00.05 in invasive ventilation modes in adult and pediatric patient categories and with the low peep alarm turned off by setting it to zero. this absence of alarms does not occur in the neonatal patient category or in non-invasive modes. this absence of alarms does not occur in system version 1.00.06 which is readily available.