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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With regard to accessories for the heartstart mrx portable external defibrillator (m5528a - mrx vehicle wall mount and m5529a - dc power module) it was determined that under certain conditions a smoke or fire hazard to patients or caregivers in proximity to the vehicle wall mount could occur. this happens only when both the vehicle wall mount and dc power module are installed together and if the user modifies the product. more specifically it was found this only occurs if the user modifies the dc output cable from either the dc power module and/or the electrical connector on the wall mount by cutting/splicing or soldering.