Events

Dräger Carina Ventilator 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Draeger Australia Pty Ltd 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-2018-RN-00394-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-05-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00394-1
  • 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
    Draeger has been made aware that one component in the valve assembly of the carina ventilator was not sufficiently cleaned by a supplier. over time, this can result in the material of the valve assembly becoming corroded and can result in contamination of the breathing gas.This issue was identified during production at dräger. to date, no reports of adverse events have been received as a result of this issue.
  • 조치
    Draeger is advising customers to remove the potentially affected devices from use immediately to exclude any further risk to patients. Draeger will provide affected sites with loan devices to alleviate any delays and/or downtime. Draeger will contact users (via Engineering Department) to schedule the replacement of the affected components.

Device

Dräger Carina Ventilator
  • 모델명 / 제조번호(시리얼번호)
    Dräger Carina VentilatorSerial Numbers: ASKM-0074; ASKM-0075; ASKM-0076; ASKM-0077; ASKM-0078; ASKM-0079; ASKM-0080; ASKM-0082; ASKM-0083; ASKM-0084; ASKM-0085; ASKM-0086; ASKM-0087; and ASKM-0088ARTG Number: 140966(Draeger Australia - Ventilator, adult)
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd