Alerta De Seguridad para Surgical Table for Small, Medium and High Surgery, model BF686-Registro Anvisa: 8000960006

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BARRFAB Indústria e Comércio Ltda..

¿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
    1228
  • Fecha
    2012-04-27
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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 advises that after the cleaning process, disinfection of metal surfaces using alcohol-based disinfectant should be carried out according to the instructions for use of the equipment - Operating Table for small, medium and high surgery, delivery and obstetrics model 686 (Barrfab, 2006). When using other disinfectants, note that maximum concentration values ​​should not be exceeded. If there is no means to ensure the indicated concentration, active chlorine-releasing compounds (most commonly used compounds, sodium hypochlorite, calcium and lithium) should not be used for disinfection, risk of corrosion to metals. If you have any questions regarding the information contained in this release, please contact the manufacturer at (54) 2628.8808, 2628.8800, 2628.8803 or administracao@barrfab.com.br. The Technovigilance Unit will monitor the progress of the actions.
  • Causa
    Possibility of oxidation / corrosion in some parts of the table.
  • Acción
    Customer survey of oxidation / corrosion occurrence or not