Alerta De Seguridad para AVEA PULMONARY FAN - registration 80071310004 - Models no. 17310, 17311, 17312, 17610, 17611, 17612 of all the manufactured units from 01/03/2009 to 06/30/2011.

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.

Since the second semester of 2011, from its headquarters in São Paulo / SP, from changes in work orders, changes were observed in some modules of DW (Module responsible for pneumatic controls of the Pulmonary Ventilator) above that considered normal. Since it is a highly complex piece, the company decided to alert its partner (manufacturer) in the USA on these technical issues in order to evaluate the performance of these modules, as it is responsible for the Design Controls of the equipment. From this information, the manufacturer has initiated a series of studies and tests in order to find out the causes of the defects presented by the modules. At the beginning of the year 2012, the manufacturer company realized that the defect could be solved from the change of the TCA plate (Module Command Board). Also, according to the manufacturer, the sequence of alarms presented by the equipment when faulty, is as follows: 1) High Peak Pressure; 2) Safety Valve (Release of Safety Valve); 3) Circuit occlusion; 4) Low PEEP; 5) Low Exhalation Volume. These alarms refer to the equipment sending a high peak pressure to the patient in their ventilatory modes. In this way, the equipment activates the mechanism of releasing the safety valves, releasing the pressure, in order to avoid any possible possibility of harm to the patient. There are no notification records in the NOTIVISA system. Anvisa is following this action.