Events

Turning aids: ReTurn 7400 and ReTurn 7500 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Handicare AB 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/2014/025
  • 사례 연번
    CON432862
  • 날짜
    2014-07-02
  • 사례 출판 날짜
    2014-07-02
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON432862?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
    The wing handle on the ladder part of the turning aid may become loose, with a risk of harm to the patient and the person operating the device. the manufacturer has developed an inspection protocol, which is set out in its field safety notice (fsn) dated 19 march 2014. handicare has not had sufficient confirmation from users that they have received and acted upon the information contained in the fsn.
  • 조치
    Identify any affected devices as described in the Field Safety Notice. Where appropriate, remove affected components and contact Handicare for replacements. If you service or recondition these devices, make sure you use the latest version of the service manual to inspect the wing handles, catches and ladders.

Device

Turning aids: ReTurn 7400 and ReTurn 7500
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Turning aids: ReTurn 7400 and ReTurn 7500. Specific design is affected. What is affected: The spare part 'wing handles', article number 7322, delivered from June 2009 to July 2011 inclusive. Any ReTurn 7400 or ReTurn 7500 with the ladder attached to the chassis, delivered until May 2011, might have the affected wing handle (see FSN for further details).
  • Manufacturer
    Handicare AB

Manufacturer

Handicare AB