Events

SOMNOvent CR and prismaCR 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Weinmann Geräte für Medizin GmbH + Co.KG 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
    Field Safety Notice
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    The medical device manufacturer resmed has published safety information, in which it reported results of the serve-hf study which indicate a significant increase in the annual death risk in patients who have received adaptive servo-ventilation (asv) therapy. according to the results, patients with symptomatic chronic heart failure, a left ventricular ejection fraction (lvef) of ≤ 45% and central sleep apnea who were treated with the devices used in the study were at a higher risk of death than patients in the control group. although the individual asv algorithms used by the manufacturers differ widely, at the present time the possibility cannot be ruled out that treatment with the weinmann devices somnovent cr and prismacr for adaptive servo-ventilation could cause a deterioration in the state of health of at-risk patients with the clinical symptoms stated above. .

Device

SOMNOvent CR and prismaCR

Manufacturer

Weinmann Geräte für Medizin GmbH + Co.KG