Events

eVent Medical Inspiration LS & i Series Ventilator Systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia 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-01059-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-10-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01059-1
  • 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
    Investigations have identified that a component on the systems power board can fail in a manner which can cause the ventilator to shut down without the alarm being triggered. this failure could result in death or serious injury to a patient.
  • 조치
    Users should discontinue use of the affected ventilators immediately until correction is completed. The manufacturer, eVent Medical has identified a correction to this issue which requires removal of the potentially faulty component from the power board. The corrective action will be undertaken by Taleb Medical during the month of November 2015. This action has been closed-out on 17/08/2016.

Device

eVent Medical Inspiration LS & i Series Ventilator Systems

Manufacturer

The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia