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 Inc..

¿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
    A1506-258
  • Número del evento
    2011DM-0007955
  • Fecha
    2015-06-22
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=177
  • 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 the previous fans allow doctors to deactivate all alarms, including those that detect the disconnection of the circuit, it is possible that a disconnection of the circuit that occurs and pass unnoticed may lead to inadequate ventilation and damage to the patient, which may entail to potentially present serious adverse events on the patient.

Device

Invasive and non-invasive ventilation system
  • Modelo / Serial
    Astral 100 and 150.
  • Descripción del producto
    The stellar ventilation system is designed to provide ventilation to adult and pediatric patients who are not dependent (13 kg / 30 lb or more), who breathe freely and who have partial or total respiratory failure, with or without obstructive sleep apnea. The device is for non-invasive use, or for invasive use with a sleeveless or sleeveless tracheotomy tube. Parauso in the hospital or at home.
  • Manufacturer
    Resmed Inc.

Manufacturer

Resmed Inc.
  • Empresa matriz del fabricante (2017)
    ResMed, Inc.
  • Source
    NIDFSINVIMA