Alerta De Seguridad para lung ventilators

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VENT-LOGOS Sistema Logístico S/A.

¿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
    759
  • Fecha
    2003-12-23
  • 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
    considering the provisions of paragraph 3 of Article 111 of the Internal Regulation approved by Administrative Rule no. 593, dated August 25, 2000, republished on December 22, 2000; considering items IV, XXIX, and XXXV of Art.10, of Law no. 6.437, of August 20, 1977; considering Arts. 1, 12, 17 item X and 25, of Law no. 6.360 / 76, of September 23, 1976; considering art. 1 of DRC-59, of 27 June 2000; considering a report of the joint inspection with the Technical Team of the Sanitary Surveillance of the Secretary of State of Health of Espírito Santo on December 5, 2003, reporting the nonconformities recorded in the Company's Quality System VENT-LOGOS SISTEMAS LOGISTICOS S / A, ; considering the Notice of Infringement No. 307935 and the Term of Interdiction No. 307935 issued by the State Department of Health of the State of Espírito Santo, resolves: Article 1 - To determine, as a precautionary measure, throughout the national territory, suspension of sale and banning of all products (pulmonary ventilators)
  • Causa
    Failure to comply with the requirements of good manufacturing practices established in drc 59/00;.
  • Acción
    Suspension of sale and banning of all products

Device

Manufacturer