Events

Action® 2000 Manual Wheelchairs 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Invacare Ireland Limited 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
    Field Safety Notice
  • 사례 연번
    SN2011(28)
  • 날짜
    2011-11-24
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/action-2000-manual-wheelchairs&id=6581f825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • 데이터 추가 비고
  • 원인
    In august 2007, invacare changed the method of mounting the castor assembly to the sideframe. the thread length on the bolts used to mount the castors were found to be insufficient to guarantee that the bolts can be correctly tightened. loose bolts could potentially cause the sudden failure of one or both of the castor housing bolts, and the possibility of a fall from the wheelchair which could result in injury to the user.
  • 조치
    The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected wheelchairs.  3. If you / your institution have affected wheelchairs, follow the manufacturer’s recommendations as outlined in the attached field safety notice and ensure that the corrective action is completed on all affected medical devices.

Device

Action® 2000 Manual Wheelchairs
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Action® 2000 Manual Wheelchairs
  • Manufacturer
    Invacare Ireland Limited

Manufacturer

Invacare Ireland Limited