Events

Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare 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-2014-RN-01266-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-12-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01266-1
  • 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
    Following an internal investigation triggered by reports in the field, it was identified that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. this could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all. in such a situation the inability to defibrillate or a delay in doing so can as a consequence lead to the death or severe injury of the patient. this potential malfunction can occur with these electrodes after a duration of storage of about 2 years or more.
  • 조치
    Customers are advised to quarantine affected lot numbers and return for replacement This action has been closed-out on 24/05/2016.

Device

Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators
  • 모델명 / 제조번호(시리얼번호)
    Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillatorsProduct Codes: 2059144-001 & 2059144-005 (DF69, 50461)Lot numbers: 21003-0770, 21113-0777 & 21220-0771ARTG number: 208134
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd