Events

Alerta De Seguridad para X-ray Imaging System O-ARM 1000

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 Navigation 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
    I1607-282
  • Número del evento
    2009EBC-0005097
  • Fecha
    2016-07-19
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=131
  • 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 identified that the referenced equipment requires some updates to continue to comply with the current operating standards, which include software updates to correct technical and hardware changes to the battery pack, leading to potential adverse events being presented to patients.

Device

X-ray Imaging System O-ARM 1000
  • Modelo / Serial
    O-ARM 1000, serial 00703.
  • Descripción del producto
    The O-ARM® system is a multidimensional surgical imaging platform optimized for use in spine surgeries and surgeries related to orthopedic trauma. It brings intraoperative image projection to a new level with superior quality of the image and visual field in 2 and 3 dimensions, allowing the surgeon to confirm the accuracy of advanced surgical procedures before the patient leaves the operating room. Integrating seamlessly with navigation, the O-ARM ® SYSTEM reduces x-ray exposure, increasing safety for both medical personnel and patients.
  • Manufacturer
    Medtronic Navigation Inc

Manufacturer

Medtronic Navigation Inc
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NIDFSINVIMA