Events

K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Invacare 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
    SN2006(08)
  • 날짜
    2006-11-20
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/k--series-competition-compact-compact-hemi-combi-drive-kid-and-ultra-light-wheelchairs&id=a494f825-9782-6eee-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
    The wheelchair seat covers manufactured by invacare between february and october 2003 were supplied with a covering material, which did not meet the requirements for flammability defined by the manufacturer.
  • 조치
    Ensure that the purchaser and prescribers of these devices within your healthcare institution:   1. Identify all K-series, competition, compact, compact-hemi drive, kid and Ultra light seat covers that were supplied to your healthcare institution in 2003  2. Arrange with your supplier (Invacare Ireland or Lifestyle Mobility) to check the seat cover material.  The inside of the non-flame retardant cover is black while the inside of the flame retardant cover is grey.  3. Ensure that all affected seat covers are replaced with new covers.

Device

K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs
  • Manufacturer
    Invacare

Manufacturer

Invacare