Events

Notificaciones De Seguridad De Campo acerca de Puma, Beatle, Alex & Ibis XP Power Wheelchairs

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

¿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
    SN2014(04)
  • Fecha
    2014-02-20
  • 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=/puma-beatle-alex-ibis-xp-power-wheelchairs&id=d778f825-9782-6eee-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
    Handicare has identified a potential issue with the compact lights on puma, beatle, alex and ibis xp power wheelchairs. the lights might cause overheating and as a result, parts of the compact lights unit could melt or, in extreme situations, ignite. handicare and healthcare 21 have successfully exchanged 33 units of the 87 placed on the irish market. there are 54 units in ireland which cannot be located and require an exchange.
  • Acción
    The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected power wheelchairs.  3. If you / your institution have any affected power wheelchairs, please stop using the front and rear light (blinkers can still be used) and contact your local dealer or Healthcare 21.

Device

Puma, Beatle, Alex & Ibis XP Power Wheelchairs
  • Modelo / Serial
  • Descripción del producto
    Puma, Beatle, Alex & Ibis XP Power Wheelchairs
  • Manufacturer
    Handicare

Manufacturer

Handicare