Events

Flow Generator with Heated Humidifier and Accessories, VPAP Tx and VPAP Adapt SV Models, Registration - 80047300518, Serial Numbers - Annex 1 and 2. //// VPAP ADAPT SV, VPAP ADAPT SV and S9 VPAP ADAPT models Brazil - 36097, registration 80047300198, risk class III. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA.; RESMED LTD 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1598
  • 날짜
    2015-05-29
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    The identified safety problem represents a significant increase in the risk of cardiovascular death in patients with symptomatic chronic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) who are being treated with Adaptive Servoventilation.
  • 원인
    During the preliminary analysis of primary data from the serve-hf clinical study, a serious safety concern was identified. this study investigated the effect of adaptive servo injection (vsa) therapy on hospitalization rates and mortality in patients with symptomatic chronic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef ≤ 45%) and central apnea moderate to severe predominant sleep (ahi ≥ 15 / h, cahi / ahi ≥ 50% and cai ≥ 10 / h).
  • 조치
    The company advises physicians who accompany patients with symptomatic chronic heart failure with reduced ejection fraction who are using ResMed VSA devices to contact these patients to discuss discontinuation of treatment. Further information in Annexes 3, 4 and 5.

Device

Flow Generator with Heated Humidifier and Accessories, VPAP Tx and VPAP Adapt SV Models, Registra...

Manufacturer

MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA.; RESMED LTD
  • Source
    ANVSANVISA