Events

Philips HeartStart MRx Monitor/Defibrillator with Q-CPRAFFECTED PRODUCTSProduct: Q-CPR meter and CPR sensor used with Philips HeartStart MRx Monitor/Defibrillator with Q-CPR option. 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-2015-RN-00832-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-08-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00832-1
  • 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
    Adhesive pads:during internal review, philips identified that the instructions on attaching the q-cpr meter adhesive pad to the q-cpr meter could be improved. patient chest injury:instructions did not inform the users that properly performed cpr can result in injuries to the patient.
  • 조치
    Philips has updated the HeartStart MRx’s Instructions for Use associated with Q-CPR meter and CPR sensor via an addendum. The addendum has instructions on application of the disposable adhesive pads, which are used with the Q-CPR meter, including a diagram which illustrates proper placement and orientation of this pad. In addition, the addendum includes general information on the types of injuries, which may occur during CPR. This action has been closed-out on 24/08/2016.

Device

Philips HeartStart MRx Monitor/Defibrillator with Q-CPRAFFECTED PRODUCTSProduct: Q-CPR meter and ...
  • 모델명 / 제조번호(시리얼번호)
    Philips HeartStart MRx Monitor/Defibrillator with Q-CPRAFFECTED PRODUCTSProduct: Q-CPR meter and CPR sensor used with Philips HeartStart MRx Monitor/Defibrillator with Q-CPR option.Units Affected: All Q-CPR meter and CPR sensor, models 453564145481, 453564257691, and M4761A are affected.ARTG: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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