Events

Auxiliary common gas outlet (ACGO) for anaesthetic machine 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 GE Healthcare 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 연번
    MDA/2011/108
  • 날짜
    2011-12-01
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-auxiliary-common-gas-outlet-acgo-for-anaesthetic-machine-no-fresh-gas-flow-to-patient-with-wrong-setting
  • 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
    The accidental, incorrect setting of the ACGO switch will result in no fresh gas flow to the patient.Furthermore, if the circle breathing circuit is incorrectly attached to the ACGO, this may result in patient barotrauma.
  • 원인
    (ge healthcare) accidental incorrect setting of the acgo switch results in no fresh gas flow to the patient.(mda/2011/108).
  • 조치
    If you have these machines, ensure that:the position of the ACGO lever and breathing circuit connections are checked before the start of every case, as recommended by the manufacturers and in the Association of Anaesthetists of Great Britain and Ireland (AAGBI) pre-use checklist -  care is especially recommended for paediatric lists where breathing circuits are changed routinely between patients relevant members of staff have been fully trained in the use of these anaesthetic machines and are aware of the manufacturer’s training guidance produced in collaboration with the Safety Committee of AAGBI – see appendix of PDF below.

Device

Auxiliary common gas outlet (ACGO) for anaesthetic machine
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Anaesthetic machine: Auxiliary Common Gas Outlet (ACGO).All Aestiva, Aisys, Aespire and Avance anaesthetic machines.Manufactured by GE Healthcare.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • 제조사 주소
    Paul Mardle, UK Regulatory Affairs David Walker, UK Product Manager GE Healthcare Tel: 01707 263 570Email: paul.mardle@med.ge.comor david.walker@med.ge.com
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    MHRA