Events

Alerta De Seguridad para Surgical table for small, medium and high surgery, delivery, obstetrics and orthopedics - Model 683 - ANVISA Registry No. 80009860007

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 IMPORTAÇÃO E EXPORTAÇÃO DE EQUIPAMENTOS HOSPITALARES 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
    1258
  • Fecha
    2013-05-09
  • 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
    An investigation was carried out which resulted in the incorrect use of the oil that impaired the performance of the actuator of the elevation, generating a decrease in system performance. For further information: E-mail: administracao@barrfab.com.br; Phone: 54-2628-8808; Correspondence: Rua Mario Ely, 271 - Fiftieth anniversary - Farroupilha - RS- CEP: 95180-000. Access to the letter, see the link: http://portal.anvisa.gov.br/wps/wcm/connect/6ff373004f8f339d868bf79a71dcc661/Carta_Cliente.pdf?MOD=AJPERES
  • Causa
    Observed during laboratory test failure, in items 20 of iec 60601 and 21.101 of iec 60601-2-46. during the test of item 20 there was reduction of dielectric strength, by crushing the power cable. for item 21.101 there was loss of performance of the lift actuator, which yielded with 482kg.
  • Acción
    Notice to customers and authorized representatives; Evaluation with the customers of the possibility of replacing components.

Device

Surgical table for small, medium and high surgery, delivery, obstetrics and orthopedics - Model 6...

Manufacturer

BARRFAB INDÚSTRIA E COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE EQUIPAMENTOS HOSPITALARES LTDA