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 become aware that some pas-210 active speaker assemblies in use with the philips intellivue information center (piic) have experienced intermittent audio or loss of audio. after investigation it was determined that the speaker failures may delay recognition of an alarm condition if operators do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system e.G. a bedside monitor. this may result in delayed treatment of the patient.