Events

Alerta De Seguridad para Electromyograph NEUROMAX, XCALIBUR

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 Natus Medical Incorporated (Incorporated Dba Excel Tech || Limited) || Alpine Biomed Aps.

¿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
    I1501-43
  • Número del evento
    2009DM-0004064
  • Fecha
    2015-01-23
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=187
  • 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 when the protektoriom software for remote monitoring is used with the local acquisition system and configured to block the remote acquisition changes, in these conditions, if the remote user tries to stop the free-running waveform group, the system can display a message that this has sufficient privileges to perform this action and the waveform in the remote system will no longer update the physiological data, but the stamp of time on the label will be updated, these conditions could be present in epworks versions prior to 6.0, leading to present possible adverse events on patients.

Device

Electromyograph NEUROMAX, XCALIBUR

Manufacturer

Natus Medical Incorporated (Incorporated Dba Excel Tech || Limited) || Alpine Biomed Aps