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 an internal component on the heartstart mrx therapy board may malfunction potentially affecting the ability to deliver therapy. specifically the mrx may be unable to charge and deliver a shock. in addition when used for external pacing the malfunction may result in a loss of capture during pacing. the mrx may display a red x in the ready for use (rfu) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing.