Events

Fabius Anaesthesia Machine 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Draeger Medical 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-2013-RN-00835-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00835-1
  • 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
    Some units did not pass the high voltage test during the final checking of the fabius by the manufacturer. investigations carried out revealed that on some power supply units, the required minimum clearance between an electrical component and the unit housing was not maintained. under the influence of mechanical forces (e.G., movement of the device), this may result in small bypass currents flowing in the interior of the unit which in extreme cases cause failure of the automatic ventilation function of the device. when such faults occur, the standard required manual ventilation is possible, an acoustic alarm is generated and the indicators on the device flash.
  • 조치
    As an interim measure, Draeger Medical is advising users to switch over to manual ventilation mode should users experience a failure of the automatic ventilation function. The power supply units will be replaced as a permanent correction.

Device

Fabius Anaesthesia Machine
  • 모델명 / 제조번호(시리얼번호)
    Fabius Anaesthesia MachineSupplied between February to July 2013Serial Number: ASEC-0203ARTG Number: 104223
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd