Events

Notificaciones De Seguridad De Campo acerca de K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs

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

¿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
    SN2006(08)
  • Fecha
    2006-11-20
  • 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=/k--series-competition-compact-compact-hemi-combi-drive-kid-and-ultra-light-wheelchairs&id=a494f825-9782-6eee-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 wheelchair seat covers manufactured by invacare between february and october 2003 were supplied with a covering material, which did not meet the requirements for flammability defined by the manufacturer.
  • Acción
    Ensure that the purchaser and prescribers of these devices within your healthcare institution:   1. Identify all K-series, competition, compact, compact-hemi drive, kid and Ultra light seat covers that were supplied to your healthcare institution in 2003  2. Arrange with your supplier (Invacare Ireland or Lifestyle Mobility) to check the seat cover material.  The inside of the non-flame retardant cover is black while the inside of the flame retardant cover is grey.  3. Ensure that all affected seat covers are replaced with new covers.

Device

K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs
  • Modelo / Serial
  • Descripción del producto
    K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs
  • Manufacturer
    Invacare

Manufacturer

Invacare