Events

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 Pride Mobility Products Ltd 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/2014/011
  • 사례 연번
    CON395248
  • 날짜
    2014-03-21
  • 사례 출판 날짜
    2014-03-21
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON395248?tabName=allTabs
  • 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
    Potential for injury should wheelchairs be secured into vehicles incorrectly.  pride mobility has updated their transportation documentation (dated september 2013); this includes safety-critical information.  in particular, the guidance on how to secure powered wheelchairs requiring more than four tie-downs has been clarified. pride mobility issued a field safety notices in october 2013.  however, it is not clear whether users have received and acted upon this new guidance.
  • 조치
    Identify all users who may have a Pride Mobility powered wheelchair that is suitable for occupied use in transport Ensure users and those involved in transporting the wheelchairs are made aware of the revised transportation guidance. Users should follow the revised transportation guidance to ensure that the wheelchairs are being transported correctly. Complete and return the Notification of Updated Transportation Information form (supplied with the Field Safety Notices to Pride Mobility. Action by: All those involved in the provision, prescription, use and transport of wheelchairs. In particular: wheelchair service managers, rehabilitation engineers, occupational therapists and patient transport service managers.

Device

Powered wheelchairs
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Powered wheelchairs manufactured by Pride Mobility Products Ltd. All models suitable for occupied use in vehicles are affected.
  • Manufacturer
    Pride Mobility Products Ltd

Manufacturer

Pride Mobility Products Ltd