Events

H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / Clamp Accessory 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Smiths 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
    Field Safety Notice
  • 사례 연번
    SN2008(02)
  • 날짜
    2008-01-31
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/h-1200-fast-fluid-warmer-with-integrated-air-detector-clamp-and-h-31b-and-h-30-air-detector-clamp-accessory&id=0594f825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • 데이터 추가 비고
  • 원인
    The risk of air embolism if the power of the fluid warmer unit is interrupted either manually or through power failure during an air detection event.
  • 조치
    Further to this incident the Irish Medicines Board (IMB) advises users to discontinue the use of the device until further notice.   Identify and quarantine affected devices until further notice.   If no alternative fluid warmer is available, ensure users are aware of the advice provided in the manufacturer’s customer letter (copy attached as appendix 1) and ensure that the quick reference guide is attached to all affected devices.   Contact the manufacturer to request a copy of quick reference guide if not attached to all affected devices

Device

H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / C...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / Clamp Accessory
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical