Events

Alerta De Seguridad para Invasive and non-invasive ventilation system

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 Resmed Paris || Resmed West Coast Warehouse || Resmed Germany Inc || Resmed Ltd || Resmed-Duncan Distribution Center || Resmed Asia Operations Pty Ltd || Resmed Corp.

¿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
    I1408-343
  • Número del evento
    2011DM -0007955
  • Fecha
    2014-08-25
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=197
  • 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 and informs that the procedure described in the instructions of the user guide refers to the way of configuring the breathing circuit for impedance measurement and tuning of the fan before they can be misinterpreted by the user, resulting in the pressure delivered by the user. the equipment may be incorrect or the visual pressure does not correspond to the pressure exerted by the equipment, which may lead to adverse events occurring in the patient.

Device

Invasive and non-invasive ventilation system

Manufacturer

Resmed Paris || Resmed West Coast Warehouse || Resmed Germany Inc || Resmed Ltd || Resmed-Duncan ...
  • Empresa matriz del fabricante (2017)
    ResMed, Inc.
  • Source
    NIDFSINVIMA