Events

Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 (manual 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-2012-RN-00738-3
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-07-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00738-3
  • 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
    Some heartstart mrx monitor/defibrillators may contain compromised electronic components and present the following behaviours:·in automatic external defibrillator (aed) mode, the mrx may have difficulty interpreting the pads ecg waveform. the mrx may incorrectly analyse the rhythm or may fail to analyse the rhythm.· in manual defibrillation mode, if the pads/paddles ecg signal is viewed, the user may have trouble interpreting the pads/paddles waveform and determining whether or not to deliver therapy.· when using q-cpr measurement and feedback, the feedback on ventilation rate may be inaccurate.
  • 조치
    Philips is replacing the affected component at customer facilities and is providing preventative/work around instructions.

Device

Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, M3536M4, M...
  • 모델명 / 제조번호(시리얼번호)
    Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 (manual defibrillator)Multiple affected units ARTG Number: 95661
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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