Events

Safety Alert for Open and Closed Incubator

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Ge Klinik Sistemier Tic A.S. || Ohmeda Medical.

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
    I1701-1
  • Event Number
    2008EBC-0002081
  • Date
    2017-01-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=108
  • 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 reports that it has detected the possibility of reheating certain power cables, which could cause fire, carbonization, smoke or sparks in their connector, leading to the occurrence of potential adverse events on the patient or users.

Device

Open and Closed Incubator
  • Model / Serial
    Giraffe OmniBed 6650-0036-901 and Giraffe Incubator 6651-0039-901
  • Product Description
    Thermal regulation by temperature control of the baby skin or by temperature control through a programmable heater.
  • Manufacturer
    Ge Klinik Sistemier Tic A.S. || Ohmeda Medical

Manufacturer

Ge Klinik Sistemier Tic A.S. || Ohmeda Medical