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 philips heartstart mrx monitor/defibrillator can deliver a non-synchronized shock in the synchronized cardioversion mode as follows: this rare condition can occur if the specific steps for delivering a synchronized shock in the heartstart mrx instructions for use are not followed. if the user rotates the therapy knob while simultaneously pressing the sync button then charges the mrx and presses the shock button the mrx could deliver a non-synchronized shock. the mrx will still display r wave markers as if normally operating in synchronized cardioversion mode. the "sync" label will still be seen on the display. when the mrx is charged and the shock button pressed the shock will be immediately delivered and may not be synchronized to the r wave. in addition the label affixed to the top of the mrx device is not consistent with the mrx instructions for use on synchronized cardioversion.