Events

Neonatal and paediatric endotracheal tube clamp/holder 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 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
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2012/049
  • 사례 연번
    CON174833
  • 날짜
    2012-07-23
  • 사례 출판 날짜
    2012-07-23
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON174833?tabName=allTabs
  • 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
    Risk of airway loss due to slippage of the clamp/holder or airway obstruction as a result of over-tightening of the clamp/holder. ems medical has gone into administration and therefore cannot be contacted.   the mhra has issued this medical device alert to ensure that all users are aware of this issue. 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 before this issue was identified and it is not known how many affected devices have been supplied.
  • 조치
    Identify, do not use and dispose of affected devices.

Device

Neonatal and paediatric endotracheal tube clamp/holder
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Neonatal and paediatric endotracheal tube clamp/holder. All product codes. All lot numbers. This device assists in securing an endotracheal tube (ETT) in position for neonatal and paediatric patients.
  • Manufacturer
    EMS Medical

Manufacturer

EMS Medical
  • Source
    MHRA