Events

Field Safety Notices about Trilogy 100, Trilogy 200, Garbin, Garbin Plus, Trilogy O2, Trilogy 202, Trilogy EC

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 KONINKLIJKE PHILIPS N.V..

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
    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.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    AMPMDRS