Retiro De Equipo (Recall) de AVEA ventilator

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Carefusion 211 Inc dba Carefusion.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Ventilator, continuous, facility use - Product Code CBK
  • Causa
    A pressure transducer failure can develop, activating a false extended high ppeak or circuit occlusion alarm. the safety valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. the malfunction may delay initiation or cease ventilation. nonbreathing patients will need manual ventilation or to be connected to another ventilator.
  • Acción
    A customer letter dated 4/21/15 will be sent to all customers who received the AVEA Ventilator, all models, to inform them that CareFusion has identified a potential risk associated with AVEA Ventilator caused by a malfunction of a pressure transducer. The malfunctioning pressure transducer is detected and by design ceases ventilation and opens the safety valve to atmosphere allowing spontaneous breathing of patients capable of doing so. The non-breathing patient would need to be manually ventilated. The letter informs the customers of the issues, the potential risk, and the actions to be taken. Customers are instructed to contact CareFusion Recall Support Center at (888) 562-6018, (858) 617-5300, or email for recall related questions. Customers are instructed to contact CareFusion Technical Support/Customer Advocacy at (800) 231-2466, (714) 283-2228, or email for Product Technical Support Adverse Event Reporting. CareFusion posted a press release on their website on 5/27/15 and it was sent to PRNewswire. The press release provided an update on a global voluntary recall that was initiated on April 21, 2015 to address an issue with certain units of AVEA ventilators. The press release provide the problems and the actions to be taken. The press also list the countries that are affected by the recall.


  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution. US Nationwide including Guam and Puerto Rico, Canada, Albania, American Samoa, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bolivia, Bosnia Herzegovina, Brazil, Bulgaria, Chile, China (Peoples Rep), Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvadore, Estonia, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Rep), Kuwait, Latvia, Lebanon, Libyan Jamahiriya, Lithuania, Malaysia, Mexico, Moldova, Morocco, Nepal, Netherlands, Nicaragua, Norway, Occupied Palestinian Territory, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, South Africa, South America, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.
  • Descripción del producto
    CareFusion AVEA ventilator, all models. || Product Usage: || A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
  • Manufacturer


  • Dirección del fabricante
    Carefusion 211 Inc dba Carefusion, 22745 Savi Ranch Pkwy, Yorba Linda CA 92887-4668
  • Source