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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Physio-control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. the symptoms of these failures may include unexpected power on and power off device lock-up or a failure to power on or off any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death. these failures are the result of manufacturing process residue located beneath a component mounted on the power printed circuit board assembly (pcba). there have been no adverse events reported as a result of this issue.