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 HeartWare 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 030 05 18 001
  • 사례 시작날짜
    2018-06-09
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12739
  • 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
    Heartware, now a part of medtronic, is providing this letter to inform you of the potential for a transient interruption of the electrical connection between an hvad system power source (battery, ac adapter, or dc adapter) and the hvad controller that may result in unintended power switching to the secondary power source and/or unexpected audible tones (“beeping”). this interruption, which occurs while the power source remains physically connected, is due to oxidation of connecting surfaces between a power source connector and the controller’s power source socket, and typically lasts 1-2 seconds. unexpected beeping occurs when the interruption automatically resolves and may cause confusion to the patient or caregiver, as the controller may display sufficient battery capacity or ac/dc connectivity at the time of the audible tone. a critical battery alarm may also be momentarily displayed due to this phenomenon.

Device

Medtronic HeartWare™ HVAD™ System
  • 모델명 / 제조번호(시리얼번호)
    Models: 1400, 1401, 1403, 1407, 1420, 1435, 1440, 1425, 1430, 1650
  • 의료기기 분류등급
    Cardiovascular Devices
  • 제품 설명
    Circulatory Assist Units, Cardiac, Ventricular
  • Manufacturer
    HeartWare Inc.

Manufacturer

HeartWare Inc.
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • 제조사 대표
    Medtronic Saudi Arabia
  • Source
    SFDA