Events

Alerta De Seguridad para Mechanical fans for adults, model Evita Infinity V500 and Pediatric/Neonatal fans model Babylog VN 500

Según National Drugs Administration from El Salvador (DNM), este evento ( alerta de seguridad ) involucró a un dispositivo médico en El Salvador que fue producido por manufacturer #8473.

¿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
  • Clase de Riesgo del Evento
    Class I
  • Fecha
    2015-07-13
  • País del evento
    El Salvador
  • Fuente del evento
    DNM
  • URL de la fuente del evento
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • Notas / Alertas
    Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 data from the U.S. and El Salvador.
  • Notas adicionales en la data
  • Causa
    The cause of the alert is battery faults of the ps500 model, which does not last as expected, even the indicator shows load when it does not. the alert is made to the battery is not related to the whole team. it was verified that 6 fans had been marketed to the first of may hospital of the isss which proceeded to change the model of the defective battery after the alert. inspections of the fans of these models have been carried out and the battery that is in health alert has not been found.
  • Acción
    Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment. - Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices

Device

Mechanical fans for adults, model Evita Infinity V500 and Pediatric/Neonatal fans model Babylog V...

Manufacturer

manufacturer #8473
  • 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
    NDAESDNM