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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Vapotherm has received a small number of complaints involving a defect in the disposable patient circuit that allows water to leak into the center gas lumen that is beyond what would be attributed to normal condensation. recall has been issued to raise awareness of this issue and to remind users to follow the instructions for use recommendation that the cannula be connected to the patient only after the set temperature is reached.