Events

Volker LTC bed (with lateral release button for the side rails) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Iona Medical Products 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-00835-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00835-1
  • 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
    Hill-rom has received notice that a side rail of a 2080 bed lowered unintentionally and abruptly when a patient leaned over the side rail with his full body weight. hill-rom have evaluated the potential risk and determined a likelihood of occurrence less than 9/100,000 units or 0.009%.Hill-rom would like to remind users of the bed rails of 2080 beds with lateral release buttons for the side rails of the proper use of side rails. if a patient needs to exit the bed, please lower the side rails and not directly load the rail with the full patient weight.
  • 조치
    Hill Rom is advising users to ensure the bed rails are lowered before bed egress or patient assisted during egress of the bed. Hill Rom will be providing a service kit to be installed by a qualified service representative in order to correct the issue.

Device

Volker LTC bed (with lateral release button for the side rails)
  • 모델명 / 제조번호(시리얼번호)
    Volker LTC bed (with lateral release button for the side rails)Model Number: 2080 FSSerial Number: 2080-2007-51-46ARTG Number: 96733
  • Manufacturer
    Iona Medical Products

Manufacturer

Iona Medical Products