Events

Alerta De Seguridad para Respironics ventilator

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 Respironics 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
    R1402-83
  • Número del evento
    INVIMA 2009EBC-0004309
  • Fecha
    2014-02-20
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=208
  • 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
    It is affirmed that the ventilators of the models mentioned commercialized between december 31, 2013 and january 30, 2014, contain a potentially defective ferrite component that could affect the operation of the biomedical equipment, causing a failure in the mechanical ventilation and in the functionality of the alarm that can be reduce only to indicate ventilatory insufficiency, leading to the potential occurrence of adverse events on the patient causing serious deterioration in their health condition or even death.

Device

Respironics ventilator
  • Modelo / Serial
    TRILOGY 100, 200 and 202
  • Descripción del producto
    This unit can facilitate non-invasive or invasive ventilation. It can be used to provide patients with total ventilation therapy as they move from a noninvasive to an invasive way.
  • Manufacturer
    Respironics Inc

Manufacturer

Respironics Inc
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NIDFSINVIMA