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 Physio-Control Inc. 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 031 05 18 000
  • 사례 시작날짜
    2018-05-09
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12582
  • 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
    Physio-control has become aware of an issue where the etco2 reading can intermittently show a value of “xxx” after start-up or during device operation. during the investigation, the manufacturer of the etco2 module found that compressed air may have contaminated filters within in the etco2 module. as a result of the contamination of the filter, the etco2 display on the lifepak 12 or lifepak 15 will provide a reading of “xxx”. there may be solid or dashed lines present on the device display in the place of an etco2 waveform and the service led will be illuminated. in this situation, the etco2 monitoring functionality will no longer be available.

Device

LIFEPAK® 15 and LIFEPAK® 12 with End-Tidal CO2 option
  • 모델명 / 제조번호(시리얼번호)
    LIFEPAK® 15 Monitor/Defibrillator and LIFEPAK® 12 Defibrillator/Monitor with End-Tidal CO2 option
  • 제품 설명
    Monitor/Defibrillator
  • Manufacturer
    Physio-Control Inc.

Manufacturer

Physio-Control Inc.
  • 제조사 모회사 (2017)
    Stryker
  • 제조사 대표
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA