Events

Alerta De Seguridad para MONOPACIENT HYPERBARIC SYSTEM ECOBAR 800. Model: ECOBAR 800. ANVISA Register: 80009380003.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ECOTEC EQUIPAMENTOS E SISTEMAS 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
    1375
  • Fecha
    2014-04-03
  • 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
    According to the manufacturer of the product, under high concentrations of oxygen and pressure, there is a risk of spontaneous combustion of titanium alloys and other substances mentioned. Spontaneous combustion is related to some characteristics of these materials, together with the concentrations of ambient oxygen - titanium alloys IN CONTACT with an environment of high concentration of O2 (inside the chamber) can undergo a process of spontaneous combustion.
  • Causa
    Hyperbaric systems, especially those pressurized with oxygen, should not be used in patients with external orthopedic fixators built in titanium and in composite materials, such as carbon fiber and fiber, for the risk of potential fire.
  • Acción
    Security alert.

Device

MONOPACIENT HYPERBARIC SYSTEM ECOBAR 800. Model: ECOBAR 800. ANVISA Register: 80009380003.

Manufacturer

ECOTEC EQUIPAMENTOS E SISTEMAS LTDA.
  • Source
    ANVSANVISA