Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Philips Healthcare 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
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 126 05 18 000
  • 사례 시작날짜
    2018-05-28
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=15&rid=12681
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: SFDA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    An issue with one of the electronic components (a resistor) in approximately 660,000 aeds that were manufactured between 2002-2013. virtually all of these resistor-related failures were detected through the devices automatic self-testing, alerting the user by issuing audible chirps. philips claimed that in-use reliability of these aeds is greater than 99.9% when the aed determines a cardiac arrest victim is in need of shock therapy. as well as philips claimed, in rare instances, self-tests might not identify a problem and the device might not deliver a shock when needed. to date, philips is aware of 13 instances outside saudi arabia in which this component failed during treatment due to the aforementioned issue.

Device

HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs
  • 모델명 / 제조번호(시리얼번호)
    Philips AED Models: HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs manufactured from September 2002 through February 2013. Please check attachment for how to identify affected products.
  • 제품 설명
    Defibrillator/Cardioverters
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • 제조사 모회사 (2017)
    Philips
  • 제조사 대표
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA