Events

LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators (AED) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Physio-Control Australia Pty 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-00211-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-03-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00211-1
  • 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
    In some rare situations, the charge-pak replaceable battery charger has not lasted two years because of an internal electrical failure that leads to early internal battery depletion.
  • 조치
    End users are instructed to continue to monitor the AED routinely for warning indicators as stated in the instructions for use. If it is determined that the device is affected by the early battery depletion issue a permanent replacement device will be provided. This action has been closed-out on 04/04/2017.

Device

LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators (AED)

Manufacturer

Physio-Control Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA