MICRO-PACE REF 4580 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/2013/036
  • 날짜
    2013-05-31
  • 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
    Update to MDA/2013/001 (55Kb) and MDA/2012/070 (67Kb) on the return to market of the MICRO-PACE REF 4580.In January 2013 the MHRA issued Medical Device Alert MDA/2013/001 advising that Pace Medical had decided to cease further sales of MICRO-PACE REF 4580 external pacemakers in response to safety concerns. The MDA also gave advice on risk management for units already in use.We have since carried out an audit of both Pace Medical’s US manufacturing site and the UK authorised representative’s premises. Following this audit the manufacturer provided satisfactory responses in the areas of post-market surveillance where deficiencies had been found.Although the MHRA has received a small number of adverse incident reports involving this external pacemaker model, since our last MDA in January 2013, the manufacturer has provided sufficient feedback during our investigations to reassure us that these were not related to any new root causes. Nevertheless, clinicians should continue to closely monitor the safe operation of these devices and to report any new incidents to both the MHRA and the manufacturer.In consultation with the MHRA, Pace Medical has now decided to resume sales of MICRO-PACE REF 4580 external pacemakers in the UK and elsewhere. We will continue to scrutinise the safety of these devices and review the appropriateness of this decision in light of any new information arising from further reported incidents, or other sources.In addition, we have asked Pace Medical to remove all affected devices from UK hospitals which still require any one of the three modifications described in MDA/2012/070. The company has already confirmed that they now have enough loan units available to allow this process to take place without service disruption.Pace Medical has also recently confirmed that their products are currently sold with a statement that their expected service life is ten years from the date of purchase, and that they will not service or repair product returned after this time. Although this information was not provided when older devices were sold, they have confirmed that this condition for servicing or repair applies retrospectively to all Pace Medical devices.
  • 원인
    (pace medical and distributed in uk by apc cardiovascular) ensure continued, heightened vigilance in monitoring. (mda/2013/036).
  • 조치
    Remove from service any devices still awaiting any of the 3 modifications detailed in MDA/2012/070 (67Kb), until these have been completed.Ensure continued, heightened vigilance in monitoring the safe operation of these pacemakers in use, and in reporting any new incidents to both Pace Medical and the MHRA.Review routine pacemaker servicing schedules, taking account of the ten year service life for all Pace Medical devices.

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