Events

Retiro De Equipo (Recall) de Quickie Q7 Manual Wheelchair

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Sunrise Medical 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-2016-RN-00892-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-07
  • 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-2016-RN-00892-1
  • 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
    It has been identified that over time, and under some usage conditions, the backrest brackets may break and detach from the chair frame. if a backrest bracket breaks and goes unnoticed by the user or care giver, there is a risk that the occupant could fall out of the seat and sustain injury to the head or lower back. the expected failure rate of the issue is 1.75%. there have been four reported injuries as a result of users unexpectedly falling from the seats. if a backrest bracket breaks and goes unnoticed by the user or caregiver, there is a risk for the occupant to fall out of the seat and sustain an injury to the head or lower back.
  • Acción
    Consumers will be contacted by the dealer who supplied the device to arrange replacement of affected backrest brackets. Sunrise Medical is providing dealers with a replacement bracket kit to be installed on all affected wheelchairs. Wheelchairs manufactured after 27 November 2013 are unaffected by this issue. For more details, please see https://www.tga.gov.au/alert/quickie-q7-manual-wheelchair .

Device

Quickie Q7 Manual Wheelchair
  • Modelo / Serial
    Quickie Q7 Manual Wheelchair Model Number: EIR4Serial Number Range: R4-007239 to R4-022394Manufactured between 1 September 2009 and 27 November 2013ARTG Number: 100167
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd