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 006 12 14 000
  • 사례 시작날짜
    2014-12-01
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6798
  • 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: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    The mrx can be susceptible to one or both of the issues described below. 1. the co2 inlet port associated with end-tidal carbon dioxide (etco2) monitoring on mrx onitor/defibrillators can be pushed into the mrx housing, making it inaccessible. this can occur if the user attempts to push the co2 filterline fitting into the inlet port, instead of twisting it clockwise as described in the mrx instructions for use. 2. the handle can separate from the mrx housing due to breakage of mounts on the rear case.

Device

Philips HeartStart MRx Monitor/Defibrillator,
  • 모델명 / 제조번호(시리얼번호)
    Product: Philips HeartStart MRx Monitor/Defibrillators Units Affected: MRx units meeting one or both of the conditions described in the “How to Identify Affected Products” section of this letter, AND with a serial number within the following ranges: Model M3535A: US00100100 to US00552845 Model M3536A: US00100902 to US00552848 Model M3536M: US00500002 to US00501201 Model M3536MC: US00500001 to US00500087 Model M3536M4: US00500003, US00500004, US00552673, US00552678, US00552679 Model M3536M5: US00500001 to US00552801
  • 제품 설명
    Monitor/Defibrillator
  • Manufacturer
    Philips Healthcare

Manufacturer

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