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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Physio-control inc. lifepak 15 monitor/defibrillators with etco2 capability are distributed with the etco2 setting preset to display in mmhg. customers may choose to reconfigure the device to display the etco2 in alternative modes of kpa or % settings. when using etco2 in the kpa or % setting and in a situation where the reading is above 9.9 kpa the display of the lifepak 15 respiratory rate may partially obscure a portion of the leading digit of the etco2 value. although part of the first digit of the etco2 value is obscured by the respiratory rate the capnography waveform scale automatically adapts to the etco2 value. observing the capnography waveform and the range displayed will help the user confirm the patient's etco2 value. clinical interpretation of a low etco2 value when the value is actually high could potentially lead to incorrect treatment. there have been no reports of incorrect patient treatment or harm associated with this issue.