Events

Alerta De Seguridad para Trade name: AVEA Pulmonary Ventilator Technical Name: AVEA Ventilator Ventilator ANVISA Registration Number: 80102510942 Hazard Class: III

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR MEDICAL LTDA; Carefusion Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2174
  • Fecha
    2016-12-23
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    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.
  • Acción
    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