Events

Alerta De Seguridad para MONITOR COMPRESSOR SERVOVENTILLER. Release Information model MONTEREY COMPRESSOR

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por K. TAKAOKA INDÚSTRIA E COMÉRCIO 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
    716
  • Fecha
    2003-07-02
  • 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
    Considering paragraph 3 of art. 111 of the Internal Regulations approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering art. 7 of Law no. 6,360, of September 23, 1976, combined with art. 8 of Decree No. 79.094, of January 5, 1977, considering items 3, 4, 9.2 and 12.8.1 of the technical regulation of the general requirements of RDC No. 56, of April 6, 2001; considering also the notifications of Technovigilance that report serious adverse events with said product, resolves: Article 1 To determine, as a measure of sanitary interest, throughout the national territory, the suspension of commercialization and manufacture of the product SERVOVENTILADOR MONTEREY COMPRESSOR - Model Release # 10229820079, model MONTEREY COMPRESSOR, manufactured by K. TAKAOKA INDÚSTRIA E COMÉRCIO LTDA .------------------------ -------------------------------------------------- ------- * BRASILIA-DF, DECEMBER 27, 2004 RESOLUTION - RE Nº 1,991, OF DECEMBER 15, 2004. Considering the order placed by the Techno-surveillance Unit in file 362305 / 04-0 referring to the final report of the performance tests, safety and alarms of the ventilator Takaoka Model Monterey ventilator of the PEB-5077-B project of COPPETEC pointing satisfactory results, resolves: Art. 1º Determine the release for f opening and marketing of products SERVO VENTILADOR MONTEREY COMPRESSOR and SERVO VENTILADOR TAKAOKA, manufactured by the company K. TAKAOKA INDÚSTRIA E COMÉRCIO LTDA.
  • Causa
    Failure to meet the applicable essential safety and efficacy requirements.
  • Acción
    Determine, as a measure of sanitary interest, throughout the national territory, the suspension of commercialization and manufacture of the product, as a precautionary measure. The aforementioned company is hereby intimated in this act to present, wanting, its defense or challenge, within 15 (fifteen) days.

Device

MONITOR COMPRESSOR SERVOVENTILLER. Release Information model MONTEREY COMPRESSOR

Manufacturer

K. TAKAOKA INDÚSTRIA E COMÉRCIO LTDA
  • Source
    ANVSANVISA