Trade Name: VENTILATION SYSTEM 840 # Registration: 10349000386 -. Risk Class: III - HIGH RISK # MODELS 4-072214-00; G-062010-00. The series under risk in Brazil and the respective client are in Annex 1. 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.

Complaints have been received from clients in which they declare that the O2 sensor inside the ventilator is not working and that they need to move a patient from one ventilator to another surrogate mechanical ventilation. • If a sensor becomes nonfunctional during use and can not be recalibrated, an external oxygen monitoring device with oxygen alarm capability may be required to monitor the supplied oxygen level of the ventilator and provide the appropriate alarms. o A non-functional O2 sensor does not affect the oxygen concentration supplied by the fan and does not control the flow of gases. • If a sensor becomes non-functional and the institution's protocol requires the transfer of a patient to a surrogate ventilator, the patient should be clinically evaluated to determine the best transfer conditions to reduce patient risk. - According to information of the company the Field Action was completed.