Events

Alerta De Seguridad para ALL TWO-PHASE DEFIBRILLATORS (ALL MANUFACTURERS).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/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
    705
  • Fecha
    2003-04-17
  • 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
    For more information and information, contact Tecnovigilância / ANVISA, and inform the reference number of this Alert. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/tecnovigilancia/index.htm for you to notify if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.
  • Causa
    Defibrillators using biphasic waveforms generally require lower levels of energy to achieve defibrillation than those using single-phase waveforms. there is consequently the possibility of confusion.
  • Acción
    All users of the defibrillators should be aware of the following statement made by MHRA and reputed professional organizations. See the Annex in English at: http://devices.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwSearchResults/2AAB3B621AC478A580256D10003BB26C?OPEN - And in Portuguese at: http://www.anvisa.gov.br/ tecnovigilancia / index.htm - Tell all departments of the need to be aware of this alert.

Device

ALL TWO-PHASE DEFIBRILLATORS (ALL MANUFACTURERS).
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA