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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There may be a loss of internal communication that manages the user-adjusted nellcor spo2 alarm settings of the affected giraffe and panda ires warmer systems with nellcor spo2. the alarms may not activate as expected which can result in false positive or false negative saturation and pulse rate alarm notifications to the caregiver. the patient's oxygen saturation and pulse rate values are accurate as displayed however the displayed user-set alarm limits may be different than the actual alarm limits used for alarm activation. all other clinical functionality of the warmer is unaffected.