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 Draeger Medical Gmbh.

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
    I1408-345
  • Event Number
    2009EBC-0003254
  • Date
    2014-08-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=197
  • 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 informs that it has detected during inspections of the closing mechanism of the side panels that these are not being completely inside the guide, causing that they do not close in a completely secure way, which can lead to serious potential adverse events on the patient. .

Device

Crib of Neonatal Intensive Care BABYTHERM
  • Model / Serial
    8000WB, 8004 and 8010
  • Product Description
    This is an open care team to keep premature babies, infants and young children warm up to 8kg.
  • Manufacturer
    Draeger Medical Gmbh

Manufacturer

Draeger Medical Gmbh