Events

Retiro De Equipo (Recall) de Invacare TDX series and Storm Series power wheelchairs with 20”-24” width configurations with Formula CG Recline seating system (i.e. Tilt/Recline, Tilt/Recline/Elevate, or Recline only) and a conventional style back

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Invacare Australia 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-00356-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-04-24
  • 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-00356-1
  • 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
    Invacare has recently identified a potential pinch point affecting the wiring of the listed power wheel chairs. there is a possibility that if the slack in the wires is not routed and secured correctly, and with flexing of the back pan under the user’s weight, the headrest knob or clamp bracket may pinch, damage or cut the wire creating a hazard. smoking, sparking, burning or fire may occur if any wire in this area is repetitively pinched, at the same location, over a period of time. not all impacted chairs are expected to have slack in the wiring that is not routed and secured correctly. invacare has received one complaint and there have not been any reported events involving injury associated with this issue.
  • Acción
    Dealers are advised to identify wheelchair owners and notify them of this issue and proposed actions using the consumer letters provided by Invacare. Dealers are also advised to contact their respective customers to schedule an appointment to inspect the potentially impacted power wheelchair as soon as possible. A visual inspection of the wiring shall be conducted for each impacted chair and where required the wiring will be (corrected) routed and secured in accordance with the Power Wheelchair Wiring Guide provided to dealers. For more details, please see http://www.tga.gov.au/alert/invacare-tdx-and-storm-series-power-wheelchairs . This action has been closed-out on 18/08/2016.

Device

Invacare TDX series and Storm Series power wheelchairs with 20”-24” width configurations with For...
  • Modelo / Serial
    Invacare TDX series and Storm Series power wheelchairs with 20”-24” width configurations with Formula CG Recline seating system (i.e. Tilt/Recline, Tilt/Recline/Elevate, or Recline only) and a conventional style backModels:TDX Series: TDXSP, TDXSP-AUS, TDX SR-AUS & TDX SRStorm Series: 3GTQ-MCG, STORM TORQUE, STORM TORQUE-AUS, RANGERX, 3GRX-CG, ARROW 3G & 3GAR-TSMultiple serial numbersManufactured from October 1, 2006 - July 31, 2014ARTG number: 160385
  • Clasificación del producto
    Physical Medicine Devices
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd