Events

Arctic Sun Temperature Management System (used for regulating the temperature and circulation of water to a vest worn by the patient) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bard 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-2016-RN-01290-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01290-1
  • 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
    An additional warning is to be included in the operator's manual with the advice that the arctic sun temperature management system is not to be used in the operating room environment. this is to address concerns regarding the potential for non-tuberculous mycobacterium (ntm) bacterial transmission to a patient based on use of the device in operating rooms and sterile fields under existing labelling. the probability of harm to a patient is considered remote.
  • 조치
    Bard is providing customers with operator's manual addendum which contains the additional warning that the Arctic Sun Temperature Management System is not intended for use in the operating room environment.

Device

Arctic Sun Temperature Management System (used for regulating the temperature and circulation of ...
  • 모델명 / 제조번호(시리얼번호)
    Arctic Sun Temperature Management System (used for regulating the temperature and circulation of water to a vest worn by the patient)Arctic Sun 2000 Temperature Management System (230VAC)Product Code: 2000-03Arctic Sun 5000 Temperature Management System (220-240 V Australia)Product Code: 5000-01-03ARTG Number: 150422
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd