Events

Notificaciones De Seguridad De Campo acerca de Quickie Neon Swing-Away Wheelchairs

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Sunrise 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
    SN2011(32)
  • Fecha
    2011-12-09
  • 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=/quickie-neon-swing-away-wheelchairs&id=b380f825-9782-6eee-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
    It has come to sunrise medical’s attention through post-market surveillance activities that a small number of upper frame tubes that support the backrest have failed on the quickie neon swing-away wheelchair. there is the potential for frames to fail and users could potentially fall backwards resulting in serious injury.
  • Acción
    The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected wheelchairs.  3. If you / your institution have affected wheelchairs, please follow the manufacturer’s recommendations as outlined in the attached FSN and ensure that the corrective action is completed on all affected medical devices.

Device

Quickie Neon Swing-Away Wheelchairs
  • Modelo / Serial
  • Descripción del producto
    Quickie Neon Swing-Away Wheelchairs
  • Manufacturer
    Sunrise Medical

Manufacturer

Sunrise Medical