Events

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
    Recall
  • ID del evento
    66219
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2273-2013
  • Fecha de inicio del evento
    2013-09-05
  • Fecha de publicación del evento
    2013-09-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121778
  • 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
    Carefusion has identified a potential risk associated with avea¿ ventilators when used at higher altitudes. a proactive complaint review identified an error in the barometric pressure compensation. carefusion is voluntarily initiating a field correction of the affected devices to correct the error.
  • Acción
    CareFusion sent customer notification letters on September 05, 2013 via USPS mail return receipt carrier. The customer notification letter dated September 3, 2013 was titled "URGENT PRODUCT RECALL", and was addressed to Biomedical Engineering, Respiratory Care, and Risk Management. The customer notification letter informed customers of the product under recall with product name, description, and serial numbers enclosed as list unique to each customer. The customer notification letter also states the Problem and Affected Devices: Issue, Potential Risk, Actions to be Taken by CareFusion, Action to be Taken by the Customer, and Contact Information. Care Fusion has initiated a project to develop a new version of software that will resolve this issue. Once this software is available to download you will receive a notification letter. The customers were instructed to promptly return the enclosed Response Card to expedite the correction process and acknowledge receipt of this Notification and follow the listed instructions noted in the letter. For Recall Related and Support contact CareFusion Recall Support Center at 888.562.6018 or email: SupportCenter@carefusion .com Questions. For Product Technical Support Adverse Event Reporting contact Support/Customer Advocacy at 800.231.2466, 714.283.2228 or email to support.vent.us carefusion.com. from (6:30am -5:00pm POST). UPDATED: Firm issued press release of the recall on 09/30/2013.

Device

AVEA Ventilator
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, American Samoa, Argentina, Australia, Austria, Bahrain, Barbados, Bangladesh, Belgium, Bermuda, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile,China, Colombia, Costa Rica, Croatia, Cyprus, Czech Rep, Dominican Republic, Ecuador, Egypt, Estonia, El Salvador, Finland, France, Germany, Georgia, Greece, Guatemala, Hong Kong, Honduras, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Lybia Jamahiriya, Malaysia, Mexico, Moldova, Morocco, Netherlands, Nepal, Nicaragua, Norway, Oman, Pakistan, Palastine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Product Name: AVEA¿ Ventilator. || All Models. || The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. || A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
  • Manufacturer
    Carefusion 211 Inc dba Carefusion

Manufacturer

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