Events

Alerta De Seguridad para Respirator BiPAP AUTOSV ADVANCED SYSTEM ONE WITH HEATED TUBE, Hazard Class II, Registration 10216719019 (Series 60) /////// BiPAP AUTOSV ADVANCED SYSTEM, ONE (Series 50), Registration 10216719015,, Serial number affected: SEE ANNEX

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda.; 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
    1600
  • Fecha
    2015-06-03
  • 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
    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. #### UPDATED ON 07/18/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • 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
    According to the registry holder, up to the completion of the investigation, based on ResMed data, it is strongly recommended that clinicians follow recommendations that warn of the use of ASV therapy in patients with symptomatic chronic heart failure (NYHA 2 -4) and reduced LVEF ≤ 45%, and moderate to severe predominant central sleep apnea. Physicians who prescribe ASV therapy are advised not to place new patients in the at-risk population in the devices and to evaluate current patients. A discussion about continuity or otherwise of ASV therapy should be made if a current patient is considered within the at-risk population. Consequently, as a precaution, physicians should assess individual risks before prescribing therapy with the Philips devices listed above for the population of at-risk patients. No other patient population was identified as at risk for adverse outcomes.

Device

Respirator BiPAP AUTOSV ADVANCED SYSTEM ONE WITH HEATED TUBE, Hazard Class II, Registration 10216...

Manufacturer

Philips Medical Systems Ltda.; Respironics Inc.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA