Events

Alerta De Seguridad para Draeger mechanical fan AVOID V300, AVOID V500 and BABYLOG VN500

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 Drägerwerk Ag & Co. Kgaa || Drager Medical Gmbh.

¿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
    I1507-329
  • Número del evento
    2013EBC-0010354
  • Fecha
    2015-07-30
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=175
  • 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 states that it has detected the reduced capacity of the batteries belonging to the optional ps500 external battery, the device will activate the "low battery" sequential alarms, and it will not be possible to predict the remaining operating time until the fan stops, this behavior obeys only to the failure of the batteries and not to a damage in the main unit of ventilation, leading to the occurrence of potentially adverse events for the patient for not having backup supply, in case of absence of main power supply.

Device

Draeger mechanical fan AVOID V300, AVOID V500 and BABYLOG VN500
  • Modelo / Serial
    equipment that has the optional PS500 external battery module installed.
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    The mechanical ventilator avoids V300 is used intra - hospitally to administer invasive and non - invasive ventilatory support to adult, pediatric and neonatal patients through the generation of positive pressure endiversas ventilatory modalities: mandatory, assisted andpontaneous. Simultaneously, the team monitors the mechanics and respiratory function of the patient. Its main clinical indication is to temporarily support respiratory function in those patients who are unable to carry out an effective spontaneous respiration.
  • Manufacturer
    Drägerwerk Ag & Co. Kgaa || Drager Medical Gmbh

Manufacturer

Drägerwerk Ag & Co. Kgaa || Drager Medical Gmbh