Events

Alerta De Seguridad para WASHER AND AUTOMATIC ENDOSCOPE REPAIRER AER - registered in Anvisa under the number 80145900728 - Code 20301 - Serial numbers / Lots: EP1151741; EP1151742; EP1151744; EP1151747; EP1151715; EP1151568; EP1151390; 4024730; 3024357; EP1151459; EP115119; EP115910; EP1151116.

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 INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA A SAÚDE 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
    986
  • Fecha
    2009-09-28
  • 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 the procedures are already described in the Equipment User Manual, but the manufacturer is highlighting these instructions to reinforce that the endoscopes must be processed according to the disinfectant manufacturer's instructions for use. Failure to follow these instructions may result in improperly disinfected endoscopes.
  • Causa
    The company reports that it has detected the need to reinforce the importance of defining the disinfection cycle when using the aer endoscope automatic washer and reprocessor and remind users to observe the light on during the cycle. (source: johnson & johnson).
  • Acción
    The actions recommended to users of the product are as follows: (1) Verify receipt of the letter and the company's label; (2) Identify all affected equipment; (3) Attach the label to the front of the product; (4) Complete the form that accompanies the label and return it to the company to confirm that it has received the label to be affixed to the equipment; (5) Verify that the disinfection time is in accordance with the disinfectant manufacturer's instruction manual; (6) If the temperature of 25 ° C is as required by the disinfectant manufacturer's instructions for use, make sure that the TEMPERATURE light is on before beginning the disinfection cycle. (Source: Johnson & Johnson)

Device

WASHER AND AUTOMATIC ENDOSCOPE REPAIRER AER - registered in Anvisa under the number 80145900728 -...

Manufacturer

JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA A SAÚDE LTDA.