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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On-going monitoring of quality data determined that the risk of battery failure increases with age when a battery remains in use longer than 3 years after the date of manufacture or 5-charge-discharge cycles. such failure may result in overheating. battery management and safety practices information for the batteries m4605a/m4607a are not clearly documented in the instructions for use for intellivue patient monitors with software releases up to and including g.0.