Events

Avis De Sécurité sur BiPAP autoSV Advanced System One and others

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 KONINKLIJKE PHILIPS.

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
    Resmed has issued an urgent field safety notice that described a statistically significant 2.5 percent absolute increased annual risk of cardiovascular mortality for those randomized to a resmed adaptive servo ventilation (asv) therapy compared to the control group. in the patient population with reduced left ventricular ejection fraction (lvef ≤ 45%), 10.0 percent of the asv group experienced a cardiovascular death each year compared to 7.5 percent of the control group, representing a 33.5 percent relative increased risk of cardiovascular mortality (hr=1.335, 95%ci=(1.070, 1.666), p‐value= 0.010). philips is actively evaluating the information provided by resmed and examining if this might impact the medical care of patients who use the philips devices listed above.

Device

BiPAP autoSV Advanced System One and others

Manufacturer

KONINKLIJKE PHILIPS
  • Société-mère du fabricant (2017)
    Philips
  • Source
    AMPMDRS