Events

Alerta De Seguridad para Ventilation support system BIPAP, Bipap Auto SV, registration 80102510425, risk class II, all batches.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR Medical Importadora e Distribuidora de Produtos Médicos; Respironics Inc. (Currently Philips Respironics).

¿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
    1646
  • Fecha
    2015-07-22
  • 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. There were no questions associated with the performance of the VSA therapy device in the study
  • Causa
    Resmed has issued an urgent safety notice describing an absolute greater annual risk of a statistically significant 2.5 percent cardiovascular mortality rate for individuals randomized to resmed assisted ventilation (asv) therapy compared to the control group. in the population of patients with reduced left ventricular ejection fraction (lvef ≤ 45%), 10% of the asv group suffered vascular death per year compared to 7.5% of the control group, representing a higher risk of cardiovascular mortality (hr = 1.335, 95% ci - (1.070, 1.666), p value = 0.010).
  • Acción
    The registry holder recommends not placing new patients with symptomatic CHF (NYHA 2-4) and LVEF ≤45% and predominantly moderate to severe central sleep apnea in ASV therapy. Before using therapy, each patient should be evaluated for Heart Failure. In the case of signs and symptoms for this disease, an objective evaluation of LVEF should be performed. Current patients should also be evaluated and a discussion of whether or not therapy should be continued should be considered within the at-risk population.

Device

Ventilation support system BIPAP, Bipap Auto SV, registration 80102510425, risk class II, all bat...

Manufacturer

VR Medical Importadora e Distribuidora de Produtos Médicos; Respironics Inc. (Currently Philips R...
  • Source
    ANVSANVISA