Events

Retiro De Equipo (Recall) de James Leckey Design Mygo Stander

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Otto Bock 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-2016-RN-00854-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-29
  • 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-00854-1
  • 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 the initial design of the angle adjustment mechanism for the stander allowed the user to lock out the safety pull pin on the frame and adjust the angle of the stander using one hand. if the operator’s hand slipped off the turning handle when a patient was in the frame then the handle could “self-wind” and spin rapidly as the stander returns to the upright position. whilst there is no risk to the patient in the frame, the fast spinning handle does pose a risk of injury to the operator if they try to take hold of the handle.These issues only impact devices manufactured between january 2012 and august 2013 as the design of the pull pin safety mechanism was changed in august 2013. it is no longer possible to lock the pull pin out and two hands are now required to adjust the stander angle.
  • Acción
    Otto Bock is arranging for distributors to contact users of the affected devices and arrange for replacement of the pull-pin on the device with one that cannot be locked by the operator. The replacement safety pull pin will require the user to hold the pull pin with one hand while turning the adjustment handle with the other hand. If their hand slips off the turning handle, they can simply release the pull pin and the handle will stop winding. For more information, please see https://www.tga.gov.au/alert/james-leckey-design-mygo-stander .

Device

James Leckey Design Mygo Stander
  • Modelo / Serial
    James Leckey Design Mygo StanderMygo Stander Size 1Product Code: 143-1600Mygo Stander Size 2Product Code: 143-2600 Serial Number range: LEC/087023 to LEC/108416Manufacture dates: January 2012 to August 2013ARTG Number: 130629
  • Manufacturer
    Otto Bock Australia Pty Ltd

Manufacturer

Otto Bock Australia Pty Ltd