Events

Reliant Lifter 100 / 150 / 200 / 250 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(27)
  • 날짜
    2011-11-22
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/reliant-lifter-100-150-200-250&id=9481f825-9782-6eee-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
    Invacare have updated their instructions for use for the reliant lifter 100 / 150 / 200 / 250. the operating instruction in previous revisions of the user manual may have been misleading; in particular the guidance, given in some issues, on the appropriate use of the brakes when lifting the patient was incorrect and the instructions did not make adequate reference to taking caution when moving the hoist on uneven, rough surfaces and carpeted areas.
  • 조치
    The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected lifters.  3. If you / your institution have affected lifters, follow the manufacturer’s recommendations as outlined in the attached field safety notice.

Device

Reliant Lifter 100 / 150 / 200 / 250
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Reliant Lifter 100 / 150 / 200 / 250
  • Manufacturer
    Invacare Ireland Limited

Manufacturer

Invacare Ireland Limited