Events

Field Safety Notices about SOMNOvent CR and prismaCR

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Weinmann Geräte für Medizin GmbH + Co.KG.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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