Events

Alerta De Seguridad para Flow Generator with Heated Humidifier and Accessories, VPAP Tx and VPAP Adapt SV Models, Registration - 80047300518, Serial Numbers - Annex 1 and 2. //// VPAP ADAPT SV, VPAP ADAPT SV and S9 VPAP ADAPT models Brazil - 36097, registration 80047300198, risk class III.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA.; RESMED LTD.

¿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
    1598
  • Fecha
    2015-05-29
  • 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
    The identified safety problem represents a significant increase in the risk of cardiovascular death in patients with symptomatic chronic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) who are being treated with Adaptive Servoventilation.
  • Causa
    During the preliminary analysis of primary data from the serve-hf clinical study, a serious safety concern was identified. this study investigated the effect of adaptive servo injection (vsa) therapy on hospitalization rates and mortality in patients with symptomatic chronic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef ≤ 45%) and central apnea moderate to severe predominant sleep (ahi ≥ 15 / h, cahi / ahi ≥ 50% and cai ≥ 10 / h).
  • Acción
    The company advises physicians who accompany patients with symptomatic chronic heart failure with reduced ejection fraction who are using ResMed VSA devices to contact these patients to discuss discontinuation of treatment. Further information in Annexes 3, 4 and 5.

Device

Flow Generator with Heated Humidifier and Accessories, VPAP Tx and VPAP Adapt SV Models, Registra...

Manufacturer

MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA.; RESMED LTD
  • Source
    ANVSANVISA