Events

Safety Alert for respiratory assistance systems (CPAP / BIPAP)

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Weinmann Gerate Fur Medizin GMBH+CO.KG.

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
    I1404-141
  • Event Number
    2012DM-0008590
  • Date
    2014-04-10
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=205
  • 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 in isolated cases, that a diode in the power board can be subjected to an overvoltage, causing the power supply to be shut off and therefore the device to stop, leading to potentially adverse events occurring on the patient.

Device

respiratory assistance systems (CPAP / BIPAP)
  • Model / Serial
    VENTILOGIC LS
  • Product Description
    Treat respiratory disorders associated with sleep. Effectively prevent obstruction of the respiratory tract. Resuscitation of patients in places of relief. Controlled artificial respiration of people. Stop-respiratory therapy. Ensure a homogeneous breathing with regular respiratory parameters. Treat obstructive and restrictive disorders. Treat neurological, muscular and neuromuscular disorders. Treatments of respiratory regulation. Treat obstructive sleep apnea syndrome. (The indications and uses depend on the model or reference of the system and are mentioned in each instruction manual)
  • Manufacturer
    Weinmann Gerate Fur Medizin GMBH+CO.KG

Manufacturer

Weinmann Gerate Fur Medizin GMBH+CO.KG