Liko Multirall 200 overhead lift and S65 Carriage 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hill-Rom 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-01289-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-18
  • 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
    Hill-rom has become aware of a user-error of improper attachment of the multirall 200 overhead lift to the s65 carriage that could result in a potential safety issue. since the introduction of this combination in 2007, twenty six events have been reported where an improper connection of the s65 carriage to the multirall 200 overhead lift was not identified by the user prior to use and a disconnect occurred, resulting in the unit falling. eleven of these cases have alleged injuries to the caregiver or patient.Hill-rom would like to reinforce that the instructions relating to proper connection, including verification of proper attachment prior to use, must be followed when attaching the multirall 200 overhead lift to the s65 carriage. the instructions for proper connection are included in the instruction guide provided with the liko multirall 200 overhead lift and s65 carriage.
  • 조치
    Hill-Rom is advising users to refer to the instructions for use and additional Quick Reference Guide to aid in correct installation of the Multirall 200 overhead lift to the S65 carriage. The Quick Reference Guide also provides a link to a video that users should view for system installation/use.

Device

  • 모델명 / 제조번호(시리얼번호)
    Liko Multirall 200 overhead lift and S65 CarriageMultirall 200 overhead lift Product Number: 3130001S65 CarriageProduct Number: 3136011All Serial NumbersARTG Number: 161863
  • Manufacturer

Manufacturer