Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as part of the original order) 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-2015-RN-00098-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-02-06
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    It has been identified that specific combinations of engstrom ventilator casters and bases pose an increased likelihood of failures of the caster mounting hardware. a failure of the caster mounting hardware may result in the ventilator falling/tipping (overbalancing). a fall/tip of the engstrom ventilator can result in serious injury to patients or clinical staff.
  • 조치
    GE is replacing all affected accessory carts. End users are advised that they can continue to use the cart until replaced, however the casters must be checked for signs of damage and loosening. This action has been closed-out on 03/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as part of the original order)Serial Numbers: CBCN01062 through CBCQ01396ARTG Number: 108308
  • 의료기기 분류등급
  • Manufacturer

Manufacturer