Events

Retiro De Equipo (Recall) de Karma Wheelchairs Item Name: Flexx(KM-8022)18*18

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Independent Home Care & Surgical Supplies Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-01157-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-25
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01157-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Incorrect parts were supplied for karma wheelchairs. the bore diameter of the flexx side frame and front caster mount should be y8 to fit m8 screws. however, the flexx that was provided was y6 on the side frame and y8 on the caster mount. the production line did not realise the problem during production and assembled the caster mount to side frame by m6 screws. since the castor mount has bigger holes (y8), the wheelchair is likely to be wobbly while driving and more seriously, after a few months the m6 screws may fall off from the frame.This action was taken prior to consultation with the tga.
  • Acción
    Independent Home Care & Surgical Supplies is contacting users to correct affected units. This action has been closed-out on 11/11/2016.

Device

Karma Wheelchairs Item Name: Flexx(KM-8022)18*18

Manufacturer

Independent Home Care & Surgical Supplies Pty Ltd
  • Source
    DHTGA