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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Philips has become aware that the ecg trunk cable and connector block of the mrx could be susceptible to accelerated wear which could result in an interrupted ecg signal. interruption of the ecg signal can cause: 1. loss of demand mode pacing 2. inability to perform synchronized cardioversion with paddles 3. disruption of leads ecg monitoring which could delay appropriate treatment defibrillation fixed mode pacing ecg monitoring via pads/paddles and other monitoring functions are not impacted by this issue.