Events

Concerto & Basic Shower Trolleys (used for assisted hygiene care) 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-2016-RN-00500-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00500-1
  • 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
    As part of post market surveillance (complaint reporting) monitoring, arjohuntleigh received a limited number of complaints where the bolts under the stretcher became loose. there has been one minor injury as a result of a patient falling related to these incidents. arjohuntleigh investigated the issue and concluded the stretcher mounting bolts or stretcher tilting mechanism can become loose which may make the device unstable, providing a potential for risk to the patient or the caregiver. there is a risk the locking mechanism for the stretcher–tilt function may not engage properly, resulting in a patient falling to the floor.
  • 조치
    ArjoHuntLeigh is advising users to ensure the trolleys are checked regularly as per the Instructions for Use (IFU). ArjoHuntLeigh will be performing an inspection on all affected devices to ensure the bolts are securely fastened. This action has been closed-out on 16/02/2017.

Device

Concerto & Basic Shower Trolleys (used for assisted hygiene care)
  • 모델명 / 제조번호(시리얼번호)
    Concerto & Basic Shower Trolleys (used for assisted hygiene care)Serial Numbers: 3000846870, 3000852015, 3000856697, 3000856697, 3000856697, 3000646121, 3000674706, 3000674706, 3000676859, 3000674706,3000717577, 3000717577, 3000720597, 3000720597, 3000756366, 3000766008, 3000783964, 3000783964, 3000783964 Manufactured between 7 March 2014 and 20 April 2015ARTG Number: 199958
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd