Events

HeartStart MRx Monitor / Defibrillator 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-00622-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-06-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00622-1
  • 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 mrx could deliver a non-synchronised shock in the cardioversion mode if the user rotates the therapy knob while simultaneously pressing the 'sync' button, then charges the mrx and presses the shock button. delivery of a non-synchronised cardioversion shock could result in the delivery of incorrect therapy, which may induce ventricular fibrillation.Additionally, the label affixed to the top of the mrx device is not consistent with the instructions for use with regard to the specific steps for the set up of delivery of a synchronised shock.
  • 조치
    Philips Healthcare are providing users with work around instruction as an interim measure. A software upgrade and device label revision will be supplied to users as a permanent fix. This action has been closed-out on 11/02/2016.

Device

HeartStart MRx Monitor / Defibrillator
  • 모델명 / 제조번호(시리얼번호)
    HeartStart MRx Monitor / DefibrillatorModel numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6Serial Numbers: All serial numbers between US00100100 to US00567299Manufactured between February 2004 and May 2013ARTG Number: 95661
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA