Events

Avis De Sécurité sur Trilogy 100, Trilogy 200, Garbin, Garbin Plus, Trilogy O2, Trilogy 202, Trilogy EC

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 N.V..

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
    Philips respironics trilogy devices operating with the above software versions and with dual prescriptions enabled may be susceptible to inadvertent change between active prescriptions in response to specific user interaction. this may occur without requiring user confirmation of the change. however, devices continue to accurately display the active prescription in the upper left hand corner of the display. the device does not change spontaneously. if the user is unaware of the change between prescriptions, this could pose a risk to patients. there have been no reports of harm or injury associated with this issue. .

Device

Trilogy 100, Trilogy 200, Garbin, Garbin Plus, Trilogy O2, Trilogy 202, Trilogy EC

Manufacturer

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