Events

Safety Alert for anesthesia machine

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by GE Medical Systems China Co, Ltd. || Datex - Ohmeda Inc..

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
    I1705-192
  • Event Number
    2008EBC-0001418
  • Date
    2017-05-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=85
  • 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 there may be an incomplete seal between disposable evaporator and the lower assembly of the breathing circuit, this incomplete seal may allow to re-inhale the patient's gases resulting in high levels of co2 (hypercapnia), additionally in the carestation 600 series systems an unexpected transition may occur to a fault state displaying the error "system failure" causing the interruption of the operation and ventilatory support, this could lead to the occurrence of adverse events or delays in the surgical times.

Device

anesthesia machine

Manufacturer

GE Medical Systems China Co, Ltd. || Datex - Ohmeda Inc.