Events

Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient monitor). 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-2012-RN-00805-3
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-08-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00805-3
  • 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
    The dash monitor may exhibit an unexpected loss of custom automatic nbp measurement cycling. custom automatic nbp measurement is a feature introduced in dash version 6.0 which allows the user to program up to 4 different nbp auto mode sequences. when a view of another patient with an nbp parameter on the network occurs, if the custom automatic nbp measurement cycling function is enabled, the function will turn off unexpectedly. the issue can occur when manually viewing another bed on the network using the view other beds option or automatically with the automatic view on alarm (avoa) feature.
  • 조치
    GE Healthcare is providing users with work around instructions to mitigate the issue. A software update will be implemented to permanently fix the issue when available.

Device

Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient m...
  • 모델명 / 제조번호(시리얼번호)
    Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient monitor).Monitors with software versions 6.0 and later may be affectedARTG Number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd