External pacemaker 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Pace 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 연번
    MDA/2013/001
  • 날짜
    2013-01-10
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
  • 사례 출처
    MHRA
  • 사례 출처 URL
  • 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
    Further to MDA/2012/070 addressing the potential for loss of ventricular output or sensing failure, Pace Medical Inc has temporarily withdrawn the MICRO-PACE REF 4580 from sale.Subsequent to the publication of MDA/2012/070 (67Kb) on 9 October 2012 detailing three manufacturer Field Safety Corrective Actions (FSCAs), the MHRA has received a further incident report of loss of ventricular output due to a soldering failure in a fully upgraded MICRO-PACE REF 4580 pacemaker. After discussion with the MHRA, Pace Medical Inc has decided to remove the MICRO-PACE REF 4580 device from the market. They have confirmed that no further units will be sold until the MHRA has undertaken a review of manufacturing processes, and obtained sufficient evidence to support the safety of this external pacemaker. Specifically, the MHRA will be seeking reassurance that appropriate systems and controls are in place during both the manufacturing and post-production phases to ensure that consistent and safe products are produced.MICRO-PACE REF 4580 pacemakers currently in use are not being recalled, as this could place patients at risk through lack of pacing provision, if alternative devices are not available. Instead, any risks associated with the continued use of these devices should be managed on an individual basis, with particular attention to the need for additional patient monitoring.The MHRA will issue further advice on completion of this investigation.
  • 원인
    (pace medical and distributed in the uk by apc cardiovascular) potential for loss of ventricular output or sensing failure. (mda/2013/001).
  • 조치
    Update to MDA/2012/070New units:  MICRO-PACE REF 4580 have been withdrawn from sale until further notice.  Units already in use: if insufficient alternative devices are available, continued use should be based upon an individual risk assessment of the patient, taking account of factors such as: degree of pacing dependency arrhythmia history the level of additional patient monitoring; in particular, for loss of ventricular sensing or capture.Units that have not been upgraded (see MDA/2012/070) should not be used with epicardial leads.Report all adverse incidents involving these pacemakers to the MHRA’s Adverse Incident Centre and the manufacturer.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    External pacemaker: MICRO-PACE REF 4580.Manufactured by Pace Medical and distributed in the UK by APC Cardiovascular.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Manufacturer’s authorised representative Steven Hanson or Catherine Rose Devices Ltd 28 Fiddlebridge Industrial Centre Lemsford Road Hatfield Hertfordshire AL10 0DE Tel:    01707 327 641 Fax:   01707 266 677Email:    pacemedicalpres@gmail.com
  • 제조사 모회사 (2017)
  • Source
    MHRA