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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Devices within these serial number ranges may be affected by one of both of these 2 identified. issue one: devices may intermittently or sometimes repeatedly switch themselves on and remain on for 10minutes which could eventually cause premature depletion of battery capacity. should this condition not be detected the battery may become depleted below a level where it could power the device to safely deliver therapy if required. issue two: the battery management software in affected devices may mis-interpret changes in voltage which occur during the normal operation of the device as indications of a low battery capacity. this can trigger an unnecessary low battery warning which if it occurs during an rescue event may cause the device to switch off and/or may delay the delivery of shock therapy.