Events

Safety Alert for SpO2 CO - Oximetry sensor

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

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
    I1602-52
  • Event Number
    2010DM-0005387
  • Date
    2016-02-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=157
  • 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 the referenced devices could be manufactured with incompatible configurations, leading to an erroneous reading of the physiological signals, leading to the potential occurrence of adverse events on the patients.

Device

SpO2 CO - Oximetry sensor
  • Model / Serial
    RAINBOW - SpCO, SpO2 and SpMet, specific batches.
  • Product Description
    Device that connects to a pulse oximeter for taking blood saturation, concentration of CO2 and CO2.
  • Manufacturer
    Masimo Corporation

Manufacturer

Masimo Corporation