Events

iMDsoft MetaVision ICU (MV-ICU), Version 5.47.4622(graphical patient information system used for data collection, management, and storage) 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-2016-RN-00188-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-02-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00188-1
  • 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
    A software issue has been identified in the medication management module which may lead to duplication of medication dose under specific settings. this can only occur when a medication order has a weekly interval (e.G., administer medication x every monday) and an attribute (e.G, dose quantity or frequency) of the order is subsequently modified.
  • 조치
    A temporary mitigation was provided by means of modifying the software configuration setting. Specifically, the proposal was to extend the time horizon from 7 days, which is equal to the dose interval, to greater than 7 days. A permanent solution will be provided once it becomes available.

Device

iMDsoft MetaVision ICU (MV-ICU), Version 5.47.4622(graphical patient information system used for ...
  • 모델명 / 제조번호(시리얼번호)
    iMDsoft MetaVision ICU (MV-ICU), Version 5.47.4622(graphical patient information system used for data collection, management, and storage)ARTG Number: 165518
  • Manufacturer
    IMDsoft

Manufacturer

IMDsoft
  • Source
    DHTGA