Events

Notificaciones De Seguridad De Campo acerca de Aquilon series of nebulisers

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por AFP Medical.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    MS35752
  • Fecha
    2018-05-29
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/aquilon-series-of-nebulisers---priority-1---for-immediate-action&id=71bf0a26-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
  • Causa
    The hpra has been informed that the aquilon series of nebulisers have been placed on the european market without appropriate ce certification. as such their safety and performance cannot be assured. this safety notice is to alert users and healthcare professionals not to use these devices.
  • Acción
    The HPRA advises that users and healthcare professionals: 1. Examine your stock to determine if you have the affected devices. 2. Identify patients who may have the devices. 3. Stop using the device immediately and use an alternative nebuliser. 4. Forward a copy of this safety notice to all relevant personnel within your organisation or to any other organisations/persons to which/whom these devices have been transferred. 5. Report any adverse events/incidents associated with these devices to the manufacturer and the HPRA.

Device

Aquilon series of nebulisers
  • Modelo / Serial
  • Descripción del producto
    Aquilon series of nebulisers - Priority 1 - For Immediate Action
  • Manufacturer
    AFP Medical

Manufacturer

AFP Medical
  • Source
    HPRA