Events

Ventilation support system BIPAP, Bipap Auto SV, registration 80102510425, risk class II, all batches. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 VR Medical Importadora e Distribuidora de Produtos Médicos; Respironics Inc. (Currently Philips Respironics) 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
    1646
  • 날짜
    2015-07-22
  • 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. There were no questions associated with the performance of the VSA therapy device in the study
  • 원인
    Resmed has issued an urgent safety notice describing an absolute greater annual risk of a statistically significant 2.5 percent cardiovascular mortality rate for individuals randomized to resmed assisted ventilation (asv) therapy compared to the control group. in the population of patients with reduced left ventricular ejection fraction (lvef ≤ 45%), 10% of the asv group suffered vascular death per year compared to 7.5% of the control group, representing a higher risk of cardiovascular mortality (hr = 1.335, 95% ci - (1.070, 1.666), p value = 0.010).
  • 조치
    The registry holder recommends not placing new patients with symptomatic CHF (NYHA 2-4) and LVEF ≤45% and predominantly moderate to severe central sleep apnea in ASV therapy. Before using therapy, each patient should be evaluated for Heart Failure. In the case of signs and symptoms for this disease, an objective evaluation of LVEF should be performed. Current patients should also be evaluated and a discussion of whether or not therapy should be continued should be considered within the at-risk population.

Device

Ventilation support system BIPAP, Bipap Auto SV, registration 80102510425, risk class II, all bat...

Manufacturer

VR Medical Importadora e Distribuidora de Produtos Médicos; Respironics Inc. (Currently Philips R...
  • Source
    ANVSANVISA