Events

MetaVision ICU version 6.0x - 6.9x 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-2017-RN-01173-2
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-09-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01173-2
  • 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 received a complaint stating that there was a malfunction with the metavision icu system that resulted in specific medication doses missing in multiple patient files. after an analysis of this complaint, imdsoft determined that:- one patient did not receive some specific planned doses that were prescribed. the problem in the software also identified to occur for few other patients, but in their case no actual doses were skipped. no grave patient outcomes have been reported.- the cause was found to be a software malfunction in the metavision code which affected the behaviour of the order management driver (omd) - part of the metavision icu medication management module. the software malfunction resulted in an unnoticed omd failure which did not create specific medication doses of medication orders exceeded the horizon of 7 days per treatment plan. this led to the non-provision of specific medication doses to several patients.
  • 조치
    1. Complete the supplied Customer Response and return it by email to FSN@imd-soft.com. 2. Contact iMDsoft Customer Support on 1800 240 919 to arrange a software upgrade to correct the problem.

Device

MetaVision ICU version 6.0x - 6.9x
  • 모델명 / 제조번호(시리얼번호)
    MetaVision ICU version 6.0x - 6.9xARTG Number: 165518
  • Manufacturer
    IMDsoft

Manufacturer

IMDsoft
  • Source
    DHTGA