Events

Alerta De Seguridad para CATHETER SOUNDSTAR ECO and NAVIGATION SYSTEM EP - CARTO 3 System, Model - Catheters and Surgical Navigation System. Registration nº 80145901453. SERIAL NUMBER: NAVIGATION SYSTEM EP - CARTO 3 System: SNs: 50573; 51027; 51021; 50572; 11879; 51022; 50203; 51018; 51020; 50128; 11179; 50530; 50532; 5977

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; BIOSENSE WEBSTER 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
    1725
  • Fecha
    2015-11-03
  • 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
    The company informs that there will be risk if the ultrasound image is being used to monitor the patient during the electrophysiology procedure. If there is a power outage during the ride, the ultrasound image will not reappear until the CARTO® 3 System is restored.
  • Causa
    The company holding the registry informs that the intracardiac ultrasound image will disappear if the power of the carto® 3 navigation system is interrupted and this may present a safety problem if the electrophysiologist is using ultrasound imaging to monitor the patient during the electrophysiology. the ultrasound image will not reappear until the carto® 3 system is restored.
  • Acción
    • Read this Field Safety Notice carefully (Appendix). • Give this notice to the people at your facility who need to be informed about the problem, including relevant clinical professionals who are involved in the use of SOUNDSTAR® eco Catheters. • Keep a copy of this letter with the product. • Be aware of this Field Safety Notification

Device

CATHETER SOUNDSTAR ECO and NAVIGATION SYSTEM EP - CARTO 3 System, Model - Catheters and Surgical ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; BIOSENSE WEBSTER INC