Events

EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 EMS 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
    SN2012(13)
  • 날짜
    2012-08-24
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/ems-medical-neonatal-paediatric-endotracheal-tube-clamp-holder&id=d27df825-9782-6eee-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 composition of the plastic used to make the clamp/holder was changed to a dehp-free material. this affected the physical properties of these components, resulting in an increased risk of slippage or tube obstruction. ems medical went into administration over one year ago before this issue was identified.  the imb included a copy of mda/2012/049 in the july monthly mailing. at that time it was not known if there were any affected devices on the irish market. the imb now believe that some devices were supplied to irish customers.
  • 조치
    The IMB advises healthcare professionals/users to:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify, do not use and dispose of affected devices.  3. Inform the IMB if you have affected devices at your institution.

Device

EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder
  • Manufacturer
    EMS Medical

Manufacturer

EMS Medical
  • Source
    HPRA