Events

Retiro De Equipo (Recall) de Panthera S3 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 Motum 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-01154-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-06
  • 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-01154-1
  • 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 discovered that a few castor forks were poorly assembled on the panthera s3 wheelchair. they lacked thread locking, loctite, between the fork and axle. this could in the worst case scenario, cause the axle to come loose from the fork and eventually cause a user to fall out the wheelchair. there have been no reports of injuries associated with this issue.
  • Acción
    Motum is advising users that the castor forks will be replaced as a permenant correction. This action has been closed-out on 23/09/2016.

Device

Panthera S3 Wheelchair
  • Modelo / Serial
    Panthera S3 WheelchairSerial Numbers: 1500087, 1400567, 1200494ARTG Number: 249595
  • Manufacturer
    Motum Pty Ltd

Manufacturer

Motum Pty Ltd