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.
데이터 추가 비고
원인
Users have replaced keyboards supplied or approved by philips with multi-media-type keyboards which have an audio volume adjustment and muting controls. this allows users to easily mute audio alarms on the intellivue information center or to reduce their volume. the alarm audio volume on beside monitors and client devices connected to the intellivue information center is not affected. although the service and installation guide includes warnings about the use of hardware and software not supplied by philips it does not specify that ignoring the warning can result in loss of alarm annunciation or in the impairment of central patient monitoring.