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.
데이터 추가 비고
원인
1. olympic cool-cap system's control module has experienced a frozen screen during the teratment of infants. when this occurs the on-screen information remains on display but the system is no longer providing cooling treatment. 2. there have been a small number of instances where the power supply within the cooling module of the olympic cool-cap system has failed.