Events

Avis De Sécurité sur SOMNOvent CR and prismaCR

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Weinmann Geräte für Medizin GmbH + Co.KG.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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