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 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
    I1512-594
  • Event Number
    2008EBC-0002021 ; 2008EBC-0002105
  • Date
    2015-12-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=163
  • 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 states that it has detected a performance problem, which can generate medical decisions when they are taken by the weight of the patient, since the weight data can remain in the equipment history and be used in a different patient, leading to potential events adverse on the patient.

Device

open and closed incubator
  • Model / Serial
    GIRAFFE OMNIBED, serial TAAU67001, TAAU67002, TAAU67003, TAAU67004, TAAU67006, TAAU67007, || TAAU67011, TAAU67012, TABU67001, TABU67002, || TABU67003, TABU67005, TABU67006, TABU67007, || TABU67008, TABU67009 and TABU67011.
  • Product Description
    Thermal regulation by temperature control of baby skin or by temperature control through a programmable heater
  • Manufacturer
    Ohmeda Medical

Manufacturer

Ohmeda Medical