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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Draeger medical systems inc. has determined through internal testing that dual hemo mcable pods with revision index (ri) 15 and 16 which are used with the draeger infinity acute care system may permit liquid ingress inconsistent with their ipx4 rating which could potentially result in an incorrect measured value of invasive blood pressure.