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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A component within the pressure switch which monitors for loss of drug supply may tear causing inomax to leak from the rear of the system. as a result the inomax cylinder empties more quickly than normal. an interruption or delay in the administration of inomax therapy may cause worsening of systemic oxygenation indices (i.E. hypoxemia especially manifested as decreased arterial oxygenation saturation) hypotension and/or increase in pulmonary arterial pressure.