Safety Alert for PULMONARY TRILOGY 100 FAN. Anvisa Record n ​​° 80102510731.

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 product registration holder is sending a Safety Notice to its customers alerting the importance of meeting the preventive maintenance frequency of the Trilogy 100 Pulmonary Ventilator, as provided in the Equipment Manufacturer's Manual: preventive maintenance should be performed every two years or after 10,000 hours of use (whichever comes first) and the piece called "Blower" must be replaced preventively every 17,500 hours of use of the device. Sudden failure of the Blower during ventilation can lead to serious adverse events. The occurrence of adverse events related to the equipment must be notified to Anvisa through the NOTIVISA system, which can be accessed through the following link: http://www.anvisa.gov.br/hotsite/notivisa/index.htm.