Events

Retiro De Equipo (Recall) de ReMed devices used for Adaptive Servo-Ventilation (ASV) TherapyAutoSet CS; AutoSet CS2; VPAP Adapt SV; S9 VPAP Adapt; VPAP Adapt; AirCurve 10 CS PaceWave; VPAP Tx; S9 VPAP Tx

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Resmed Limited.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00405-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-05-14
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00405-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    A serious safety concern has been identified during the preliminary primary data analysis from the serve-hf clinical trial. this trial investigated the effect of adaptive servo-ventilation (asv) therapy on the hospitalisation and mortality rate of patients with symptomatic, chronic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef = 45%) and moderate to severe predominant central sleep apnea. the identified safety concern is 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%) being treated with adaptive servo-ventilation.
  • Acción
    Resmed is advising physicians managing patients who are having symptomatic chronic heart failure with reduced ejection fraction and predominant central sleep apnea who are using ResMed ASV devices that they should contact their patients to discuss discontinuation of treatment. For more details, please see https://www.tga.gov.au/alert/resmed-devices-use-adaptive-servo-ventilation-therapy. This action has been closed-out on 08/08/2016.

Device

ReMed devices used for Adaptive Servo-Ventilation (ASV) TherapyAutoSet CS; AutoSet CS2; VPAP Adap...
  • Modelo / Serial
    ReMed devices used for Adaptive Servo-Ventilation (ASV) TherapyAutoSet CS (Product Code - 25005)AutoSet CS2 (Product Code - 26001)VPAP Adapt SV (Product Code - 26009)S9 VPAP Adapt (Product Code - 36367)VPAP Adapt (Product Code - 36377)AirCurve 10 CS PaceWave (Product Code - 37354)VPAP Tx (Product Code 25103)S9 VPAP Tx (Product Code 36030)ARTG Number: 118966
  • Manufacturer
    Resmed Limited

Manufacturer

Resmed Limited