Events

Quickie Q7 Manual Wheelchair 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Sunrise Medical 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-00892-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00892-1
  • 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
    It has been identified that over time, and under some usage conditions, the backrest brackets may break and detach from the chair frame. if a backrest bracket breaks and goes unnoticed by the user or care giver, there is a risk that the occupant could fall out of the seat and sustain injury to the head or lower back. the expected failure rate of the issue is 1.75%. there have been four reported injuries as a result of users unexpectedly falling from the seats. if a backrest bracket breaks and goes unnoticed by the user or caregiver, there is a risk for the occupant to fall out of the seat and sustain an injury to the head or lower back.
  • 조치
    Consumers will be contacted by the dealer who supplied the device to arrange replacement of affected backrest brackets. Sunrise Medical is providing dealers with a replacement bracket kit to be installed on all affected wheelchairs. Wheelchairs manufactured after 27 November 2013 are unaffected by this issue. For more details, please see https://www.tga.gov.au/alert/quickie-q7-manual-wheelchair .

Device

Quickie Q7 Manual Wheelchair
  • 모델명 / 제조번호(시리얼번호)
    Quickie Q7 Manual Wheelchair Model Number: EIR4Serial Number Range: R4-007239 to R4-022394Manufactured between 1 September 2009 and 27 November 2013ARTG Number: 100167
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd