Events

Alerta De Seguridad para respiratory assistance systems (CPAP / BIPAP)

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 Weinmann Gerate Fur Medizin GMBH+CO.KG.

¿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
    I1404-141
  • Número del evento
    2012DM-0008590
  • Fecha
    2014-04-10
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=205
  • 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 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)
  • Modelo / Serial
    VENTILOGIC LS
  • Descripción del producto
    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