Events

Field Safety Notices about Invivo Expression MRI Patient Monitoring System

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 Philips Medical Systems.

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 device’s labeling inaccurately indicates “endotracheal” as a body temperature application site. the flextemp reusable temperature sensor is not intended to be used for endotracheal site placement. should the flextemp reusable temperature sensor be inserted into the patient’s trachea, patient infection or airway blockage may occur if any part of the flextemp reusable temperature sensor or flextemp system jacket is left in the patient upon removal, or if the flextemp system jacket is damaged and sterilization compromised. .

Device

Invivo Expression MRI Patient Monitoring System

Manufacturer

Philips Medical Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    AMPMDRS