Events

Bag valve mask (BVM) manual resuscitation system 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Intersurgical 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/2018/009
  • 날짜
    2018-03-02
  • 사례 출판 날짜
    2018-03-02
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/bag-valve-mask-bvm-manual-resuscitation-system-risk-of-damage-to-lungs-by-delivery-of-excessive-pressure
  • 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
    Please see images in the document below which show the incorrect and correct orientation of the directional valves. The green nipples on the valves should not point in the same direction.
    Bag valve mask (BVM) manual resuscitation system MDA/2018/009
  • 원인
    Manufactured by intersurgical – valves may be incorrectly oriented, resulting in overpressure of the bag (mda/2018/009).
  • 조치
    Identify and immediately quarantine affected devices (see Field Safety Notice (FSN) for model and lot numbers). Replace with an alternative device where available. If no alternative is available, check the orientation is correct for all valves on quarantined devices before releasing them from quarantine (see Problem). This can be done without opening the packaging. Do not use if the orientation of the valve is incorrect. Follow the instructions in the manufacturer’s FSN to return affected devices. Return the response form to Intersurgical, even if you don’t have affected devices left in stock.

Device

Bag valve mask (BVM) manual resuscitation system
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Specific lot numbers from the following models are affected. See FSN for lot numbers.Intersurgical Code UDI No. NHSSC Code (England only) 7150000 5030267073238 FDE656 7151000 5030267073245 N/A 7152000 5030267073252 FDE658 7152005 5030267102259 N/A 7152006 5030267105632 N/A 7152007 5030267104901 N/A 7152012 5030267143061 N/A 7153000 5030267073276 FDD4288 7153008 5030267124473 N/A 7154000 5030267073283 FDE660
  • Manufacturer
    Intersurgical

Manufacturer

Intersurgical
  • 제조사 주소
    Intersurgical Tel: 0118 9656 362priority@intersurgical.co.uk
  • 제조사 모회사 (2017)
    Etablissement Cosmeplast
  • Source
    MHRA