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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The main board p/n 301641 installed in some medrad veris mr monitor units may be faulty and could lead to unexpected shutdown of the system while in use. this would result in the loss of vital signs information from the monitor. failure of the monitor may not only result in an inability of the user to view vital signs information but this failure may also go unrecognized. this may present an increased risk to patients who require that their vital signs be monitored while undergoing an mri exam such as those who are sedated anesthetized or who are on critical medications. thus it is required to continually monitor the system to ensure proper functioning.