Events

Aquilon series of nebulisers 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 AFP Medical 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
  • 날짜
    2018-02-22
  • 사례 출판 날짜
    2018-02-22
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/aquilon-series-of-nebulisers-ce-mark-withdrawn-and-supply-ceased
  • 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
    Following withdrawal of the CE mark for the Aquilon series of nebulisers, the manufacturer (AFP Medical) has continued to place the nebulisers on the market.The nebuliser and packaging have a CE mark but this has not been obtained through appropriate regulatory oversight.
  • 원인
    Manufactured by afp medical – do not use affected nebulisers as they have been manufactured to unknown standards and their safety cannot be verified (mda/2018/008).
  • 조치
    Identify affected devices from the list below. Identify patients and relevant healthcare professionals and advise them to: stop using and dispose of the nebulisers use an alternative nebuliser where available Patients who have any concerns should contact their GP or other healthcare professionalAction by:All medical, nursing and technical staff involved in the use and maintenance of these devices.

Device

Aquilon series of nebulisers
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series manufactured since 01 April 2015 are affected.
  • Manufacturer
    AFP Medical

Manufacturer

AFP Medical
  • Source
    MHRA