Events

HeartStart XL defibrillator/monitor with M3516A batteries 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
  • 사례 ID
    MDA/2013/066
  • 사례 연번
    CON305480
  • 날짜
    2013-08-15
  • 사례 출판 날짜
    2013-08-15
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON305480?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
    Seriousdefibrillator battery life has been reduced from 1.5 years to 1 year and the capacity test interval has been reduced from 6 months to 3 months. this applies to new batteries with the lot number prefix ‘lk’. philips is supplying an addendum with battery orders and heartstart xl monitor/defibrillator orders stating these changes (march 2013) to heartstart xl instructions for use (edition 7) and heartstart xl service manual (edition 6).
  • 조치
    Ensure all relevant staff are aware of the changes. Ensure that the addendum (see appendix) is attached to the instructions for use and service manuals accordingly. Be aware that this addendum supersedes any previous guidance given by Philips regarding battery life and capacity test frequency.

Device

HeartStart XL defibrillator/monitor with M3516A batteries
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    HeartStart XL defibrillator/monitor with M3516A batteries of lot number with ‘LK’ prefix. Distributed by Philips and Cardiac Services UK & Ireland. NB: Philips HeartStart XL batteries with lot code prefixes ‘P’, ‘R’, and ‘PCS’ are not affected by this change and continue to have a life expectancy of about 1.5 years, when properly maintained and stored, and battery capacity test intervals of 6 months (for infrequent use) or 3 months (for frequent use).  These batteries are still supported with relevant instructions for use and labelling.
  • Manufacturer
    Philips

Manufacturer

Philips
  • 제조사 모회사 (2017)
    Philips
  • Source
    MHRA