Events

Alerta De Seguridad para Flowtron intermittent pneumatic compression systems

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Arjohuntleigh Ab || Arjohuntleigh Magog Inc || Arjo Hospital Equipment Ab || Getinge (Suzhou) Co. Ltd. || Arjohungleich Polska Sp. Z.O.O.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1706-248
  • Número del evento
    2014DM-0011065
  • Fecha
    2017-06-23
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=81
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    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