Events

Alerta De Seguridad para Newport HT70 and Newport HT70 Plus ventilators

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
    2017-04-05
  • 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 that reports indicate that the ventilator can spontaneously re-establish itself during normal operation without an alarm indicating it. after restart, the fan enters the standby mode and does not resume ventilation without intervention. inspection was carried out at the distribution company where they stated that only one equipment was used that was used for demonstrations to customers and that to date there had been no sales in el salvador.
  • Acción
    Notice to the population recomending not to consume the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any pharmaceutical establishment. - Perform search of the product in the BPAs or routine searches. - To find the product in existence within the country, a national alert will be issued.

Device

Newport HT70 and Newport HT70 Plus ventilators

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