Events

Safety Alert for Continuous Positive Pressure System - CPAP

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

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
    I1407-303
  • Event Number
    2013DM-0010871
  • Date
    2014-07-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=200
  • 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 medical devices may have been manufactured and distributed without the serial number programmed into the unit, causing the "run test" message to be displayed on the screen, which may lead to confusion in the unit inventory. within the institutions.

Device

Continuous Positive Pressure System - CPAP
  • Model / Serial
    DV51D-HH, DV53D-HH, DV53D-HH-S, DV54D-HH, DV54D- HH-S, DV55D-HH, DV55D-HH-S, DV55D-S and DV57D-HH.
  • Product Description
    Treatment of nocturnal obstructive apnea in adults through continuous positive airway pressure (CPAP): sends air with continuous pressure to the upper airways to keep them open.
  • Manufacturer
    Devilbiss Healthcare Llc

Manufacturer

Devilbiss Healthcare Llc