Events

Multi parameter patient monitors 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 GE Healthcare 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
  • 날짜
    2019-02-27
  • 사례 출판 날짜
    2019-02-27
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/multi-parameter-patient-monitors-carescape-b450-b650-b850-b20-b40-b20i-b40i-b125-b105-dash-3000-4000-5000-solar-8000m-i-9500-risk-of-loss-of-patient-monitoring-mda-2019-011
  • 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
    When multiple monitors are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart, as they were designed to do. The monitor restart will not be completed until the network issue has been corrected.When there is a network overload for a prolonged time, it is also possible that a CARESCAPE Monitor B850 won't reboot but instead loses connection with the Patient Data Module (PDM) or CARESCAPE ONE Module.
    Manufactured by GE Healthcare - If networks are incorrectly configured with multiple monitors, a prolonged bandwidth overload condition may occur and cause monitors to restart.
  • 원인
    Manufactured by ge healthcare - if networks are incorrectly configured with multiple monitors, a prolonged bandwidth overload condition may occur and cause monitors to restart.
  • 조치
    Be aware of the manufacturer's 5 field safety notices (FSNs) published in 2018: GEHC Ref # 36135, 36132, 36131, 36127 and 36127A Users: the FSNs provide guidance n what to do if there is a prolonged network overload and the monitor on the network does not resume normal functionality in approximately 90 seconds. Staff responsible for network set up and maintenance: Ensure that the network in your facility meets the network configuration requirements as described in the FSNs.*If you have any questions, please contact your local GE Healthcare service representative.Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.This MDA is to ensure that all relevant organisations are aware of these issues and take relevant actions.Action byAll healthcare professionals who are responsible for or who use these devices.Deadlines for actionsActions underway: 14 March 2019Actions complete: 31 May 2019Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.Remember if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.

Device

Multi parameter patient monitors
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • 제조사 주소
    GE Healthcare Tel: 01707 263 570askuktechnicalsupport@ge.com
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    MHRA