Events

Safety Alert for Automatic CPAP device DREAMSTATION

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Respironics Respiratory Drug Delivery (Uk) Ltd || Respironics Inc || Respironics California Inc || Respironics Medical Products (Shenzhen) Co, Ltd.

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
    I1703-116
  • Event Number
    2016DM-0014710
  • Date
    2017-03-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=95
  • 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 identified that the medicoreferenced device experienced an erroneous configuration during its manufacture, which prevents the modem from making a satisfactory connection to the internet, a replacement of this modem is required to ensure a successful data transmission.

Device

Automatic CPAP device DREAMSTATION
  • Model / Serial
  • Product Description
    The CPAP DREAMSTATION device is an automated system whose indication of use is to provide the patient with a positive depression therapy in the respiratory tract for the treatment of obstructive sleep apnea (OSA) in spontaneously breathing patients weighing more than 30 kg. It can be used both at home and in a hospital or health center. The DREAMSTATIONCPAP pro can also perform CPAP check therapy, and the DREAMSTATION AUTO CPAP can perform CPAP decompression therapy and AUTO CPAP therapy. The ramp function allows you to reduce the pressure when you are trying to stay calm. The air pressure will gradually increase until reaching the prescribed pressure. It comes with accessories and accessories for its total operation.
  • Manufacturer
    Respironics Respiratory Drug Delivery (Uk) Ltd || Respironics Inc || Respironics California Inc || Respironics Medical Products (Shenzhen) Co, Ltd

Manufacturer

Respironics Respiratory Drug Delivery (Uk) Ltd || Respironics Inc || Respironics California Inc |...
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NIDFSINVIMA