Events

Safety Alert for Trade name: AVEA Pulmonary Ventilator Technical Name: AVEA Ventilator Ventilator ANVISA Registration Number: 80102510942 Hazard Class: III

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VR MEDICAL LTDA; Carefusion Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2174
  • Date
    2016-12-23
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    When the avea ventilator develops a malfunction of the pressure transducer on the ventilator, which measures the inspiratory or expiratory pressure of the circuit, a false alarm is initiated, indicating an ext high ppeak or circuit occlusion. ), depending on the specific failure mode in the pressure transducer. carefusion is voluntarily conducting a field safety corrective action to correct affected devices subject to this potential risk.
  • Action
    Field Action Code AC 1/15 triggered under the responsibility of the company VR MEDICAL LTDA. Company will make correction in the field.

Device

Trade name: AVEA Pulmonary Ventilator Technical Name: AVEA Ventilator Ventilator ANVISA Registrat...

Manufacturer

VR MEDICAL LTDA; Carefusion Inc
  • Source
    ANVSANVISA