Events

Alerta De Seguridad para MDK 2010 PLUS M - REGISTER NUMBER: 80058130006

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por CMOS DRAKE DO NORDESTE 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
    726
  • Fecha
    2003-09-15
  • 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 will contact customers who have the products affected by the recall from 08/09/2003. Means of Communication: 1) Disclosure note on the website www.cmosdrake.com.br; 2) Correspondence that will be forwarded to all customers who have purchased the product. For more information, contact the Factory / Assist. National Technician at the following addresses: Factory: Av. Uberlândia, nº187 - B. Malhado, Ilheus-BA - Zip Code: 45.650-000 - Phone: (73) 634-9119 National Technical Assistance: Av. Contorno, 3513 / 10º andar - Sta - Efigenia - Belo Horizonte-MG - Phone: (31) 2121-7316 / 2121-7323
  • Causa
    It was verified by the company, changes in values ​​in the power supply, specifically in leakage current, ground and dielectric strength. it was not verified and there is no record of risks occurred. however, this new power supply that will be offered, is totally technically suitable, without any change of value, for leakage current, ground and dielectric stiffness tests.
  • Acción
    A new power supply, model FMM100, exclusively designed for CMOS DRAKE, was designed and developed, fully compliant with the electrical safety standards, IEC-601-1, including leakage current, ground and dielectric strength, and approved in INMETRO tests , according to test report No. 55,707, June 28, 2003. Customers should send the equipment to the CMOS DRAKE factory, or National Technical Assistance.

Device

MDK 2010 PLUS M - REGISTER NUMBER: 80058130006

Manufacturer

CMOS DRAKE DO NORDESTE LTDA
  • Source
    ANVSANVISA