Events

MetaVision ICU (MV-ICU) Version 5.47 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 IMDsoft 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-00860-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-09-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00860-1
  • 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
    Imdsoft has identified a software bug in metavision 5.47 which appears when switching between patients or users. it can cause a refresh error which has the potential to cause confusion to healthcare providers reviewing patient information. this bug can lead to the title bar reflecting the previous patient details while the remainder of the patient data on screen refreshes, this causes a data mismatch and an error message to occur. the message presents the user with an option of 'retry’ or 'ignore'. if the user chooses 'ignore' it allows the data mismatch to continue.
  • 조치
    Until a permanent solution is available, users are advised to choose 'abort' should they see this error occur which causes a system restart and forces a data refresh, in parallel with their routine Patient Identification processes. Users are advised that when they move between patients or change users that they must check to ensure the patient matches the patient information on the title bar of the application. It is anticipated that a new version of the MetaVision software which fixes the software bug mentioned above will be released on 20 September 2015 and will be then available for installation. This action has been closed-out on 17/08/2016.

Device

MetaVision ICU (MV-ICU) Version 5.47
  • 모델명 / 제조번호(시리얼번호)
    MetaVision ICU (MV-ICU)Version 5.47
  • Manufacturer
    IMDsoft

Manufacturer

IMDsoft
  • Source
    DHTGA