Events

Safety Alert for Oxygen concentrator

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

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
    R1505-196
  • Event Number
    2008DM-0002624
  • Date
    2015-05-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=180
  • 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 a defective electrical component (motor start capacitor), in the referenced medical devices, which could break and cause a fire, leading to potential adverse events on patients and users.

Device

Oxygen concentrator
  • Model / Serial
    INVACARE PLATINUM IRC9LXO2AWQ, IRC5LXO2AW and IRC5LXAW, serial from 10CSZ43XXXX up to || 12GSZ62XXXX, manufactured between March 2010 and August || 2012
  • Product Description
    Electrical medical device that uses sieve technology to extract oxygen from the surrounding air and then continuously to the patient through a tube connected to a nasal cannula
  • Manufacturer
    Invacare

Manufacturer

Invacare