Events

Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power. 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Philips 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
    2018-11-29
  • 사례 출판 날짜
    2018-11-29
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/batteries-for-the-heartstart-mrx-monitor-defibrillator-may-fail-to-charge-or-to-provide-power
  • 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
    This MDA is related to our previous alert, MDA/2018/002, advising users of a significant delay in the supply of batteries for the HeartStart MRx monitor/defibrillator.The supply of batteries for these devices has been halted again due to further manufacturing problems. There is likely to be an ongoing significant delay in the fulfilment of outstanding orders.
  • 원인
    Philips m3538a lithium-ion batteries manufactured from 28 december 2017 to 20 march 2018 inclusive for the heartstart mrx monitor/defibrillator may have an internal component failure.
  • 조치
    Identify affected batteries highlighted in the manufacturer’s Field Safety Notice and remove them from service. Ensure alternative devices are available as defined in local risk assessment procedures until you can source a new battery. Follow the manufacturer’s instructions for use on battery management to keep your existing batteries in the best possible condition. Ensure there are systems in place to replace affected batteries as a priority when supplies are resumed.

Device

Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power.
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Philips

Manufacturer

Philips
  • 제조사 주소
    Clare Fripp Head of Q&R Philips UK& Tel: 07920 763 640Email: clare.fripp@philips.com
  • 제조사 모회사 (2017)
    Philips
  • Source
    MHRA