Events

HeartStart MRx and FR3 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-2018-RN-00136-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00136-1
  • 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
    Philips is sending formal notice of a medical device labeling correction to ensure the following:-heartstart mrx customers have access to the heartstart mrx addendum as a supplement to the mrx instructions for use (ifu)-heartstart fr3 customers whose q-cpr meters are used on an mrx are aware that certain information contained in the fr3 aed instructions for administrators (ifa) and the fr3 q-cpr meter instructions for use (ifu) also applies to use of the q-cp meters with the mrx.
  • 조치
    In August 2015, Philips distributed a Q-CPR Addendum to the MRx Instructions for Use (IFU). This information was already available in the HeartStart FR3 Instructions for Administrators (IFA) and the FR3 Q-CPR Meter Instructions for Use (IFU) - this was undertaken under RC-2015-RN-00832-1. Philips is requesting MRx users ensure that their copy of the MRx IFU contains the Addendum. For FR3 customers, ensure that the IFU for any MRx with which your Q-CPR Meter may be used contains the Addendum

Device

HeartStart MRx and FR3
  • 모델명 / 제조번호(시리얼번호)
    HeartStart MRx and FR3 HeartStart FR3Model Number 861388 and 861389 Q-CPR Model Number 989803149941ARTG: 280486HeartStart MRxModel Number M3535A and M3536A Q-CPR Model Numbers: 453564145481, 453564257691, 989803162401 and M4761AARTG: 95661 and 261352 (both restricted to no longer include this product)Q-CPR MeterARTG: 213197
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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