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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Some of the corometrics 171 172 173 and 174 series monitors were delivered with the fhr lower alarm limit configured incorrectly at 50 bpm (proper factory default setting is 120 bpm). a lower than expected fhr if left undetected could result in fetal bradycardia and oxygen deprivation to the fetus. there have been no injuries reported as a result of this issue.