Events

Alerta De Seguridad para MEDRAD Contrast Medium Injector

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 Bayer Medical Care 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
    A1608-357
  • Número del evento
    2009EBC-0003451
  • Fecha
    2016-08-22
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=125
  • 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 that there is an internal connection with the main computer of the workstation used in conjunction with the injection system, which can potentially present thermal events such as smoke, sparks or fire, as a consequence of the degradation in time of the shielding inside. of the connection, which can lead to the occurrence of potentially serious adverse events on the patient.

Device

MEDRAD Contrast Medium Injector
  • Modelo / Serial
    CERTEGRA workstation, reference 3030896, serials Initiated in KSA051.
  • Descripción del producto
    Indicated for CT imaging, hemodynamics, interventional cardiology, magnetic resonance imaging.
  • Manufacturer
    Bayer Medical Care Inc

Manufacturer

Bayer Medical Care Inc
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    NIDFSINVIMA