Events

Oxylog 3000 emergency/transport ventilators 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Draeger 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/2010/092
  • 사례 연번
    CON100176
  • 날짜
    2010-11-30
  • 사례 출판 날짜
    2010-11-30
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON100176?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
    Insufficient ventilation of paediatric patients when using small tidal volumes (50 -100 ml).This problem can result in gas being re-breathed and a potential dangerous rise in co2.The mhra is aware of three incidents in which the oxylog 3000 gave insufficient ventilation to small children where a tidal volume between 50 and100 ml was used. these incidents have occurred due to the dead space volume of the entire breathing circuit being too large to cope with the small set tidal volume.
  • 조치
    Ensure that all users are aware of the manufacturer’s Field Safety Notice (FSN). Users should always consider the dead space of ventilator breathing circuits when using small tidal volumes. Be aware that Draeger breathing circuits for use with the Oxylog 3000 (disposable and resusable) have a dead space of 33 ml and 35 ml respectively. If the dead space is not suitable for the intended purpose then consider using an alternative device.

Device

Oxylog 3000 emergency/transport ventilators
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    All Oxylog 3000 emergency/transport ventilators. The Oxylog 3000 is an emergency and transport ventilator capable of delivering tidal volumes (volume of gas inhaled and exhaled per breath) of 50 ml and upwards.
  • Manufacturer
    Draeger

Manufacturer

Draeger