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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Stryker medical has identified that on some units of the device there is a lack of a water temperature display while the unit is in auto mode. while in auto mode only the patient temperature is displayed along with the set point. the water display will be blank during auto mode. if the user wants to see the water temperature displayed and switches out of auto mode to manual mode then back to auto mode the therapy will be reset and may potentially cause patients to reach the set point earlier.