Events

HeartStart Automated External Defibrillator (AED) 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-00087-2
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-01-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00087-2
  • 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
    Philips is providing additional instructions for use to advise the user of the correct actions to take in the event an error notification:-if the frx or hs1 aed emits a pattern of 'single chirps' please press the blue i-button on the front of the device. the aed will tell exactly what actions to take to ensure that the device is ready for use. -if at any time during the life of the device, the frx or hs1 aed emitted or begins to emit a pattern of 'triple chirps', it is important that the device is removed from use and a philips representative is contacted. it is a signal that the device requires investigation by philips to ensure that it is ready for use.
  • 조치
    Philips is providing additional instructions advising users to contact Philips technical support if a device error occurs and the device begins to emit a triple chirp, even if the error can be cleared.

Device

HeartStart Automated External Defibrillator (AED)

Manufacturer

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