Events

Safety Alert for Temperature Monitoring System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by 3M Company || 3M Health Care.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1710-518
  • Event Number
    2014DM-0011649
  • Date
    2017-10-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=65
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer has confirmed that the detected temperature could be a little lower than the actual temperature of the patient, if the im- paired sensors are used as part of a system that is the only means of temperature monitoring, there is the possibility of performing inappropriate therapies, leading to possible adverse events on patients are presented.

Device

Temperature Monitoring System
  • Model / Serial
    Bair Hugger 36000 and SpotOn reference sensors,
  • Product Description
    The SPOTON temperature control system is a direct thermometer that uses the zero-flow thermometry-heat technique to produce an accurate estimate of the temperature of deep tissue in a person. SPOTON is used to measure, monitor, and supply the body temperature trend of adult and pediatric patients.
  • Manufacturer
    3M Company || 3M Health Care

Manufacturer

3M Company || 3M Health Care
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    NIDFSINVIMA