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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This problem affects revision c and d of the software. in rare circumstances the settings for paper scale type and recorder speed may revert back to the factory default settings which are: us paper style and 3 cm/min paper speed. this behaviour would have the most impact in europe and asia/pacific where other settings are preferred. if this change remains undectected by the user it may lead to misinterpretation of the fetal trace and potential incorrect clinical decisions regarding patient care. the problem occurs when the power-up/boot sequence of the fetal monitor is interrupted e.G. switching the monitor off or unplugging the power cord before it has completed the boot sequence and switching it on again immediately (within 60 sec) after the interruption.