Events

HeartStart XL defibrillator/monitor 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/2012/077
  • 사례 연번
    CON203886
  • 날짜
    2012-11-08
  • 사례 출판 날짜
    2012-11-08
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON203886?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
    Risk of immediate and unexpected loss of critical monitoring, defibrillation or non-invasive pacing. if a heartstart xl defibrillator/monitor is not connected to the mains and is used with a battery from the affected batch, it may shut down unexpectedly without providing the user with a low battery warning or audible alarm. the manufacturer published a field safety notice in september 2012 to notify users and prompt them to take action.  the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon.
  • 조치
    Identify HeartStart XL defibrillator/monitors with affected batteries and affected spare batteries. If you have affected batteries, follow the guidance given in the Field Safety Notice. In particular: do not use device on battery power alone, and ensure you have access to an appropriate alternative device. Contact the manufacturer to arrange for a replacement battery.

Device

HeartStart XL defibrillator/monitor
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Batteries for HeartStart XL defibrillator/monitor. Battery part number M3516A. Batch labelled ‘Made in Taiwan’ with ‘Date of Manufacture’ code ‘R-2011-12’.
  • Manufacturer
    Philips

Manufacturer

Philips
  • 제조사 모회사 (2017)
    Philips
  • Source
    MHRA