Events

Alerta De Seguridad para NIM non-invasive nerve monitoring equipment Medtronic Xomed

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 Medtronic Xomed, Inc || Medtronic Xomed Instrumentation S.A.S || Medtronic Xomed Inc. || Fidia Advance Biopolymers S.R.L.

¿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
    I1606-267
  • Número del evento
    2009DM-0003762
  • Fecha
    2016-06-30
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=134
  • 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 who has identified a problem with excessive flexing of the tube by the user, especially at a sharp or abrupt angle, can cause the electrode wires to flow into its channel in the silicone wall, leading to potential adverse events occurring in patients.

Device

NIM non-invasive nerve monitoring equipment Medtronic Xomed
  • Modelo / Serial
    Endotracheal Tube of EMG Reinforced NIM Standard and Contact, models 8229306, 8229307, 8229308, || 8229506, 8229507 and 8229508, specific lots.
  • Descripción del producto
    This device is intended for the supervision of surgical procedures for patients who require intraoperative monitoring of nerves, whose nature is non-invasive, assisting the surgeon in the location and mapping of the motor nerves through the use of EMG signals and electrical nerve stimulation. This equipment is accompanied by a series of accessories that connect to the patient in order to carry out the follow-up through the different measurements that the device performs.
  • Manufacturer
    Medtronic Xomed, Inc || Medtronic Xomed Instrumentation S.A.S || Medtronic Xomed Inc. || Fidia Advance Biopolymers S.R.L

Manufacturer

Medtronic Xomed, Inc || Medtronic Xomed Instrumentation S.A.S || Medtronic Xomed Inc. || Fidia Ad...
  • Source
    NIDFSINVIMA