Events

Ventstar disposable breathing 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 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/2014/029
  • 사례 연번
    CON437729
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON437729?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 inhalation of foreign particles. due to a manufacturing issue, there is the potential for loose adhesive residue to be inside the breathing systems.  this may enter the lungs if affected devices are used.
  • 조치
    Identify affected devices. If alternative devices from unaffected batches are available in your stocks: quarantine affected devices return them to Draeger and request replacements. If no alternative devices are available in your stocks: continue to use affected breathing systems carry out the check described in Draeger’s Field Safety Notice exercise caution in use. Contact Draeger to acknowledge receipt of the Field Safety Notice. Anaesthetists Theatre practitioners Consultant intensivists

Device

Ventstar disposable breathing systems
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Ventstar disposable breathing systems.  Part numbers 2M86841 and 2M86791. Specific batch numbers affected. The following products are affected by this action: Device description Part number Batch number (from – to inclusive) Packaging box set 2M86841 330384.001 - 331661.002 Hose packaging 2M86791 330384.001 - 331661.002 Affected devices were manufactured from January 2013 to April 2014 inclusive. These breathing systems are designed for use with the Oxylog 2000 ventilator, which is an emergency and transport ventilator. If relevant to you, the national supply codes are as follows: England NPC: FDB675 Breathing Circuit Oxylog 2000 Disposable Circuit 1.8m
  • Manufacturer
    Draeger

Manufacturer

Draeger