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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Philips has received a number of complaints of inaccurate ultrasound-derived fetal heart rate readings from users of the philips avalon fetal monitors (models fm20 fm30 fm40 and fm50). although the types of inaccuracies described in these complaints reflect known limitations inherent to ultrasound fetal heart rate monitoring the frequency of such complaints is greater for these devices than for the previous-generation philips series 50 fetal monitors. clinical decisions based on unrecognized inaccuracies in fetal heart traces may lead health care professionals to perform unnecessary interventions such as caesarean delivery fail to identify the need for interventions or fail to identify fetal distress.