Events

PDM module with Frame F5-01 used with CARESCAPE Monitor B850 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-01136-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01136-1
  • 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
    The pdm patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the f5-01 frame due to an issue with the pdm ethernet communication hardware. the communication loss may occur when the pdm is first attached to the host monitor, or it may lose communication spontaneously during use with no user action. communication is not automatically re-established. loss of communication with the host monitor results in a loss of monitoring for the parameters provided by the pdm module, however an audible and visual alarm will be displayed.
  • 조치
    GE Healthcare are providing work around instructions for users to follow. GE will be replacing the affected frames as a permanent correction. This action has been closed-out on 10/02/2016.

Device

PDM module with Frame F5-01 used with CARESCAPE Monitor B850
  • 모델명 / 제조번호(시리얼번호)
    PDM module with Frame F5-01 used with CARESCAPE Monitor B850 ARTG Number: 115304
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd