Events

Alerta De Seguridad para Non-invasive extra-thoracic ventilators Respironics, model NEV-100

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Respironics Inc.

¿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
    313
  • Fecha
    2001-10-12
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    All units manufactured between april 1992 and february 1999. a circuit failure may cause the above respirators to stop, shut down, and do not restart and / or exhibit smoke or smoke smell. the manufacturer initiated the correction by letter dated may 24, 1999.
  • Acción
    Check receipt of the letter dated May 24, 1999 from Respironics. Discontinue use of the product as soon as possible. Your local Respironics representative should have contacted you to arrange the repair of the affected ventilators. If it has not already done so, call one of the numbers below and Respironics will help you have your ventilator (s) serviced at no charge. The manufacturer states that this correction must be completed by the end of 2001. For more information, contact your local representative or Respironics at 1 (412) 731-2100 (United States).

Device

Non-invasive extra-thoracic ventilators Respironics, model NEV-100

Manufacturer

Respironics Inc
  • Source
    ANVSANVISA