Events

Astral Ventilators 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-00391-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-05-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00391-1
  • 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
    Resmed received an incident report involving circuit disconnection of a patient in a hospital where the device alarms did not operate because all alarms had been disengaged by the physician and the patient required medical intervention.
  • 조치
    ResMed advises that, as long as the disconnection alarm is not disabled for high-dependency patients who are using the device continuously, as directed in the Instructions for Use, the above safety concern will not occur. Alarm configurations can only be changed by health professionals and cannot be modified by the patient in the home. ResMed intends to release and install an updated version of Astral software, in three months’ time, in which the circuit disconnection alarm for all ventilation modes for dependent patients cannot be deactivated. For more details, please see https://www.tga.gov.au/alert/astral-100-and-astral-150-ventilators. This action has been closed-out on 05/09/2016.

Device

Astral Ventilators
  • 모델명 / 제조번호(시리얼번호)
    Astral VentilatorsAstral 100Model No: 27081Astral 150Model No: 27083ARTG Number: 219429
  • Manufacturer
    Resmed Limited

Manufacturer

Resmed Limited