Events

Puma, Beatle, Alex & Ibis XP Power Wheelchairs 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Handicare 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
    SN2014(04)
  • 날짜
    2014-02-20
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/puma-beatle-alex-ibis-xp-power-wheelchairs&id=d778f825-9782-6eee-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
    Handicare has identified a potential issue with the compact lights on puma, beatle, alex and ibis xp power wheelchairs. the lights might cause overheating and as a result, parts of the compact lights unit could melt or, in extreme situations, ignite. handicare and healthcare 21 have successfully exchanged 33 units of the 87 placed on the irish market. there are 54 units in ireland which cannot be located and require an exchange.
  • 조치
    The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected power wheelchairs.  3. If you / your institution have any affected power wheelchairs, please stop using the front and rear light (blinkers can still be used) and contact your local dealer or Healthcare 21.

Device

Puma, Beatle, Alex & Ibis XP Power Wheelchairs
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Puma, Beatle, Alex & Ibis XP Power Wheelchairs
  • Manufacturer
    Handicare

Manufacturer

Handicare