Events

BVM (Bag-Valve-Mask) manual resuscitation systems 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
  • 날짜
    2017-06-21
  • 사례 출판 날짜
    2017-06-21
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/bvm-bag-valve-mask-manual-resuscitation-systems-risk-of-delay-to-emergency-treatment
  • 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
    Manufactured by intersurgical – due to a manufacturing fault, the valve may become stuck during storage, leading to the intended tidal volume not being delivered and a delay to treatment.
  • 조치
    Identify all affected devices – see details below. Search for alternative devices to replace affected products (see appendix), and until alternative devices are available follow the guidelines in the Field Safety Notice. Once you have alternatives, quarantine the affected devices and contact Intersurgical.

Device

BVM (Bag-Valve-Mask) manual resuscitation systems
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The following model (REF number) and LOT numbers are affected:REF number LOT number NHS Supply Chain Code 7150000, 7151000, 7151001, 7152000, 7152007, 7152060, 7153000, 7154000, 7155000, 7156000 All lot numbers up to and including lot 370253 7150000 is FDE656, 7152000 is FDE658, 7153000 is FDD4288 7152003 All lot numbers up to and including lot 1170673 n/a 7150006, 7151006, 7152004, 7152005, 7152006, 7152009, 7152012, 7152014, 7152061, 7153006, 7153008 All lot numbers up to and including lot 31753734 n/a 7150170, 7151170, 7152170, 7152172, 7153170 All lot numbers up to and including lot 170504 n/a
  • Manufacturer
    Intersurgical

Manufacturer

Intersurgical
  • 제조사 주소
    Chris Randall IntersurgicalTelephone: 0118 9656 362Fax: 0118 9656 356Email: priority@intersurgical.co.uk
  • 제조사 모회사 (2017)
    Etablissement Cosmeplast
  • Source
    MHRA