Events

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 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Resmed Limited 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2015-RN-00405-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-05-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00405-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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...
  • 모델명 / 제조번호(시리얼번호)
    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