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.
데이터 추가 비고
원인
Fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could in rare instances potentially interrupt propaq lt device operations. if this unlikely event were to occur the device would either present an error screen instructing the user to restart the monitor or could instead present a blank or white screen. either screen would be accompanied by one or more blinking led lights and in either case the issue would be resolved by restarting (power cycling) the monitor. there is no risk associated with this issue other than a very short delay in obtaining patient vital signs from the propaq lt while the device is restarted.