Events

Safety Alert for Flowtron intermittent pneumatic compression systems

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Arjohuntleigh Ab || Arjohuntleigh Magog Inc || Arjo Hospital Equipment Ab || Getinge (Suzhou) Co. Ltd. || Arjohungleich Polska Sp. Z.O.O.

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
    I1706-248
  • Event Number
    2014DM-0011065
  • Date
    2017-06-23
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=81
  • 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 the devices can provide a constant pressure without triggering the alarm, in addition to the white lcd screen being observed, leading to possible adverse events on the patient.

Device

Flowtron intermittent pneumatic compression systems
  • Model / Serial
  • Product Description
    The FLOWTRON systems are non-invasive prophylactic and therapeutic systems to reduce the incidence of anomalies or vascular and venous deficiencies in the upper and lower extremities, through the technique of intermittent pneumatic compression (CNI). The application of external pneumatic compression generates an effect that simulates and / or complements the natural system of venous return that the muscles of the extremities offer. The system consists of a pump and a group of clothes that can be calf, thigh, foot, leg and arm.
  • Manufacturer
    Arjohuntleigh Ab || Arjohuntleigh Magog Inc || Arjo Hospital Equipment Ab || Getinge (Suzhou) Co. Ltd. || Arjohungleich Polska Sp. Z.O.O

Manufacturer

Arjohuntleigh Ab || Arjohuntleigh Magog Inc || Arjo Hospital Equipment Ab || Getinge (Suzhou) Co....
  • Source
    NIDFSINVIMA