Events

Alerta De Seguridad O Notificaciones De Seguridad para Professional use monitor/defibrillator

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 Stryker.

¿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
  • Número del evento
    MDA/2019/010
  • Fecha
    2019-02-20
  • Fecha de publicación del evento
    2019-02-20
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/professional-use-monitor-defibrillator-lifepak-15-risk-of-device-failure-during-patient-treatment-and-possible-failure-to-deliver-therapy
  • 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
  • Causa
    Manufactured by stryker – potential for a lock-up condition where the device becomes non-responsive after a defibrillation shock has been delivered. specific serial numbers are affected (mda/2019/010).
  • Acción
    Identify affected devices – see the manufacturer’s Field Safety Notice. Ensure alternative devices are available or request a loan device from Stryker. If no alternatives are available, perform a local risk assessment. Follow actions recommended in the manufacturer’s Field Safety Notice. Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

Professional use monitor/defibrillator
  • Modelo / Serial
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • Dirección del fabricante
    Nina Goddard Stryker UK Ltd Stryker House, Hambridge Road Newbury, Berkshire, RG14 5AWTel: 01635 262 476nina.goddard@stryker.com
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    MHRA