Events

Retiro De Equipo (Recall) de Invacare Power Wheelchairs with affected SPJ+ Joysticks and MK6i Driver Controls

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-2013-RN-00977-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-04
  • 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-2013-RN-00977-1
  • 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 identified a defect in a small percentage of crimped wire connections in certain joysticks which could result in oxidation leading to the slowdown of wheelchair speed performance over time. in a very small percentage of instances, the power wheelchair may slow down relative to the commanded speed and then recover, creating an unintended acceleration. the unintended acceleration due to this defect has resulted in a consumer's power wheelchair running into objects, which can lead to bruising, pinched fingers, and pinched hands.
  • Acción
    Invacare is providing distributors with two options to correct the affected joystick. 1) Invacare will supply the distributors with the correction kit for each affected joystick, with instructions on how to return the affected joysticks to Invacare. 2) Invacare will engage a third party to complete the correction. Distributors are required to provide the details for end users to the third party in order to correct the affected joysticks. Invacare will correspond with end users directly if this option is selected. For more details, please see http://www.tga.gov.au/safety/alerts-device-invacare-131011.htm This action has been closed-out on 11/04/2016.

Device

Invacare Power Wheelchairs with affected SPJ+ Joysticks and MK6i Driver Controls
  • Modelo / Serial
    Invacare Power Wheelchairs with affected SPJ+ Joysticks and MK6i Driver ControlsSerial numbers: 06JXXXXXXX to 13CXXXXXXX (the first two digits represent the year and the first letter represents the month i.e., A=January, B=February etc)Affected SPJ+ Joystick models are manufactured between 9 September 2009 to 21 March 2013 and MK6i Driver Controls (excluding all ASL, Sip-n-Puff and Switch control systems) are manufactured between 1 October 2006 to 21 March 2013ARTG Number: 160385
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd