Events

Avance, Amingo, Aisys Anaesthesia Devices (software version 8.00) and Avance CS Anaesthesia Devices (with software version 10.00) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare 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-01039-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-10-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01039-1
  • 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
    While operating in pressure control ventilation - volume guarantee (pcv-vg) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). exposure to excessive tidal volumes while pressure limits are maintained can result in pulmonary volutrauma and/or an increased pulmonary vascular resistance that can negatively affect cardiac filling pressure and/or stroke volume.
  • 조치
    GE Healthcare is providing users with work around instructions to follow until a software upgrade is provided to all customers by June 2014.

Device

Avance, Amingo, Aisys Anaesthesia Devices (software version 8.00) and Avance CS Anaesthesia Devic...
  • 모델명 / 제조번호(시리얼번호)
    Avance, Amingo, Aisys Anaesthesia Devices (software version 8.00) and Avance CS Anaesthesia Devices (with software version 10.00)ARTG Number: 93955
  • 의료기기 분류등급
    Anesthesiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd