Motorized Wheelchair. Invacare Motorized Wheelchair: (1) Cruiser, (2) Harrier HD, (3) Harrier Plus, (4) Harrier Special, (5) Home and Away, (8) Spectra Plus, (9) Spectra Special. Units manufactured between 1 June 2001 and 26 July 2001 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Invacare UK Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    370
  • 날짜
    2001-12-03
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    The medical devices agency (mda) has issued a safety alert informing numerous reports received by both the mda and the manufacturer that the steering wheel of the above motorized wheelchair has failed, have been disconnected due to the loosening of the central locking bolt / bolt during use. when this occurs, the user is at risk as he may lose control of the wheelchair and the tipping over chair; this problem may not be evident to the user or to the responsible professional at first sight, if not much later, when events occur. this problem has occurred because a locking thread (which is used to apply a thread-locking component, ie serves to retain the center bolts and prevent loosening during wheel work), has not been properly controlled during manufacture.
  • 조치
    Identify and isolate any motorized wheelchair, such as the one above, that has been provided since June 1, 2001. If you are not sure whether your wheelchair is affected, contact the manufacturer on the phone below to check the serial number in the archives. The manufacturer agrees to provide the replacement of the screws and pay the installation costs to the dealers / dealers recognized to repair the problems for the users. To receive the replacement screw, check the serial number, or request additional information by contacting your local representative or directly from Kevin Humphries, Invacare's technical services director, by mail at the address below, by phone at 44 (165) 664- 7327, or fax 44 (165) 664-9016.

Manufacturer

  • Source
    ANVSANVISA