Events

Rappel 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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Resmed Limited.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00405-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-05-14
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00405-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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