Events

Alerta De Seguridad para Name of the manufacturer: Generators Technical name: LEKTRAFUSE HF GENERATOR BIPOLAR Registration number ANVISA: 80136990815 Hazard class: III Affected model: GN200 Affected serial numbers: 2028, 2054, 2060, 2065, 2066, 2071, 2070, 2072, 2074, 2075 , 2077, 2079, 2081, 2083, 2089, 2094, 2149, 2151, 2152, 2153, 2155, 2156, 2172.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Laboratórios B. Braun S.A.; Aesculap AG Tuttlingen (AAG).

¿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
    2124
  • Fecha
    2016-12-19
  • 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
    Interruption of the use of said serial numbers, segregation thereof and information to Laboratorios B. Braun SA, for collection.
  • Causa
    The possibility of the occurrence of a functional disorder in the generators lektrafuse generator af bipolar (gn200) was identified. the mentioned functional disorder is detected by the equipment itself, generating a signaling to the user, unequivocally, in the form of an error message (error f008, code 26) and an acoustic alarm. the generator then enters a safe mode in which the equipment does not operate. to date, the problem in question has not caused any harm to patients.
  • Acción
    Field Action Code AC / 06/2016 triggered under the responsibility of the company Laboratorios B. Braun SA Company will collect for later return to the manufacturer.

Device

Name of the manufacturer: Generators Technical name: LEKTRAFUSE HF GENERATOR BIPOLAR Registration...

Manufacturer

Laboratórios B. Braun S.A.; Aesculap AG Tuttlingen (AAG)