Events

Enterprise and Citadel Range BedsModels: Enterprise 5000X with split safety side, Enterprise 8000X, Enterprise 9000X, Citadel and Citadel Plus 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Huntleigh Healthcare 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-2017-RN-01199-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01199-1
  • 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
    Arjo huntleigh has received customer complaints regarding the failure of gas spring (damper index no. 828.760) which did not support the safety sides properly. as a result, when safety sides are being lowered, the dampers do not slow down the movement of the side rail. in these circumstances, the dampers do not provide the correct distance between panels and the frame of the bed to ensure no entrapment of fingers.
  • 조치
    ArjoHuntleigh will be in contact with users to arrange replacement of affected gas dampeners. In the interim, users are advised to refer to the IFU for details regarding processes for safe side rail lowering, including steps that the rail should be held until completely lowered.

Device

Enterprise and Citadel Range BedsModels: Enterprise 5000X with split safety side, Enterprise 8000...
  • 모델명 / 제조번호(시리얼번호)
    Enterprise and Citadel Range BedsModels: Enterprise 5000X with split safety side, Enterprise 8000X, Enterprise 9000X, Citadel and Citadel PlusSerial Number Range: P0183010 – P0469078ARTG Number: 283224(Arjo Australia - Bed, general-purpose, electrical)
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd