Events

Drager Fabius MRI 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-2015-RN-00535-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-06-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00535-1
  • 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
    Drager became aware of cases in which the fabius mri or parts of the system were attracted by the magnetic field of the mri. if the fabius mri is positioned too close to the mri, the magnetic force of the mri can loosen parts of the fabius mri and cause personal injury.
  • 조치
    Drager Medical is updating the Instructions for Use Manual and the device labelling clearly state that the device must only be used in areas where the field intensity is no more than 40 mTesla. Additionally, the ventilator door will be altered to include another lock in addition to the existing locking mechanism. This action has been closed-out on 15/08/2016.

Device

Drager Fabius MRI Anaesthesia Machine

Manufacturer

Draeger Medical Australia Pty Ltd