Alerte De Sécurité sur Trade name: Oxymag - Transport and Emergency Ventilator. Technical Name: Fan Pressure and Volume. ANVISA registration number: 80659160004. Class of risk: III - High Risk. The equipment was commercialized in Brazil and in other countries. See attached.

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.

The manufacturer recommends that when detecting that the equipment switches the parameter setting page unintentionally, this unit must be segregated and the local representative must be activated. According to the company, this situation can occur when there is an electrostatic discharge of very high voltages, higher than the values ​​established in standard and the probability of occurrence increases in low humidity environments. Changing the button material increases the degree of protection of the equipment against electrostatic discharge even though the current button meets the ELETROMAGNETIC COMPATIBILITY standard requirement. In addition, the alarm system continues to operate and the unit continues to ventilate normally. Therefore, the risk associated with failure was considered low. No additional risks were identified from the button change since it is already used in another line of equipment of the company for the same application. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link