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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Drager had been informed about one case in which the neonatal patient was not adequately ventilated in high frequency oscillation (hfo) ventilation mode. the patient desaturated no permanent patient injury occured. investigations have shown that the instability of the mean airway pressure caused insufficient gas exchange resulting in the desaturation of the patient.