Trade name: AVEA Pulmonary Ventilator Technical Name: AVEA Ventilator Ventilator ANVISA Registration Number: 80102510942 Hazard Class: III 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.

CareFusion is not asking you to return your devices. • Please send us the enclosed response card to expedite the correction process and confirm receipt of this notification. • You will be contacted by your CareFusion distributor to arrange onsite remediation of affected devices; in the meantime, if any of your institution's AVEA fan units display a continuous Ext High Ppeak or Circuit Occlusion alarm, followed by the Safety Valve opening, immediately remove the service fan, provide alternative ventilation, and contact your dealer or CareFusion Technical Support using the contact information listed below to report the problem.