Events

Safety Alert for Crib of Neonatal Intensive Care BABYTHERM

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Drägerwerk Ag & Co. Kgaa.

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
    I1607-272
  • Event Number
    2009EBC-0003254
  • Date
    2016-07-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=132
  • 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 identified that after the use of the skin temperature sensor without contact with the patient, the high-power radiant heating operates continuously, forced to a high thermal load, causing the heating element to suffer premature aging, which could lead to the present potentially adverse events on patients or users.

Device

Crib of Neonatal Intensive Care BABYTHERM
  • Model / Serial
    BABYTHERM 8004/8010, specific serials.
  • Product Description
    This is an open care team to keep premature babies, infants and young children warm up to 8kg.
  • Manufacturer
    Drägerwerk Ag & Co. Kgaa

Manufacturer

Drägerwerk Ag & Co. Kgaa