Puma and Beatle battery powered wheelchairs 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Movingpeople 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2008/052
  • 사례 연번
    CON020687
  • 날짜
    2008-07-21
  • 사례 국가
  • 사례 출처
    MHRA
  • 사례 출처 URL
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Some variants of the puma and beatle are too heavy for standard four point webbing tie-down systems for use in a vehicle. a basic puma or beatle battery powered wheelchair can be transported using a four point webbing tie-down rated for a 140 kg wheelchair. however, some wheelchairs have additional features such as seat risers, tilt-in-space functions and powered elevating leg rests etc. therefore, some variants of the puma and beatle battery powered wheelchairs weigh in excess of 140kg and are too heavy for the standard four point webbing tie-down system available for use in a vehicle. guidance on how to verify the weight of the unoccupied wheelchair can also be found in the field safety notice (see appendix). if a vehicle is involved in an impact there is a risk that the tie-down will fail, potentially leading to injury of the wheelchair user and others. the manufacturer has been unable to recommend a tie-down system for wheelchairs weighing over 140 kg and has issued a field safety notice (see appendix) recommending that they are not used as a seat in transport.
  • 조치
    Trace all Puma and Beatle battery powered wheelchairs manufactured by Movingpeople.net or Handicare. Advise users of these wheelchairs not to use the wheelchair as a seat in transport when secured using standard four point webbing tie-downs until such time as they can verify that it weighs less than 140kg.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Puma and Beatle battery powered wheelchairs manufactured by Movingpeople.net or Handicare.
  • Manufacturer

Manufacturer

  • Source
    MHRA