Events

Alerta De Seguridad O Notificaciones De Seguridad para Aquilon series of nebulisers

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom 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
    Safety alert / Field Safety Notice
  • Fecha
    2018-02-22
  • Fecha de publicación del evento
    2018-02-22
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/aquilon-series-of-nebulisers-ce-mark-withdrawn-and-supply-ceased
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
    Following withdrawal of the CE mark for the Aquilon series of nebulisers, the manufacturer (AFP Medical) has continued to place the nebulisers on the market.The nebuliser and packaging have a CE mark but this has not been obtained through appropriate regulatory oversight.
  • Causa
    Manufactured by afp medical – do not use affected nebulisers as they have been manufactured to unknown standards and their safety cannot be verified (mda/2018/008).
  • Acción
    Identify affected devices from the list below. Identify patients and relevant healthcare professionals and advise them to: stop using and dispose of the nebulisers use an alternative nebuliser where available Patients who have any concerns should contact their GP or other healthcare professionalAction by:All medical, nursing and technical staff involved in the use and maintenance of these devices.

Device

Aquilon series of nebulisers
  • Modelo / Serial
  • Descripción del producto
    Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series manufactured since 01 April 2015 are affected.
  • Manufacturer
    AFP Medical

Manufacturer

AFP Medical
  • Source
    MHRA