Events

Dräger Fabius Anaesthesia Machine Device's : Fabius Plus XL, Fabius Tiro, Fabius Tiro, Fabius GS Premium, Fabius Plus XL 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-00158-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-02-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00158-1
  • 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
    Dräger has become aware of one case where the automatic ventilation failed during the operation of a fabius unit. this was due to the motor moving beyond the upper position and thereby damaging the ventilator cover. ventilation of the patient could reportedly be continued by means of the manspont mode and a manual resuscitator.No serious injury has been reported to date.As a precaution drager will be updating relevant units.
  • 조치
    Drager is advising they are currently producing replacement motors for the potentially affected devices. Dräger Service have ordered the replacement motor(s) and on receipt of the part from Germany, will contact the Biomedical Engineering team to arrange free of charge, the installation and testing of the replacement motor. In the interim, users may continue to operate the anaesthesia device with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for Use.

Device

Dräger Fabius Anaesthesia Machine Device's : Fabius Plus XL, Fabius Tiro, Fabius Tiro, Fabius GS ...
  • 모델명 / 제조번호(시리얼번호)
    Dräger Fabius Anaesthesia MachineDevice's : Fabius Plus XL, Fabius Tiro, Fabius Tiro, Fabius GS Premium, Fabius Plus XLSerial Number's :ASKM-0047, ASKH-0027, ASKH-0168, ASKH-0140, ASKM-0246ARTG Number: 104223Draeger Australia - Anaesthesia system
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd