Events

Notificaciones De Seguridad De Campo acerca de SOMNOvent CR and prismaCR

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Weinmann Geräte für Medizin GmbH + Co.KG.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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