Events

Retiro De Equipo (Recall) de Shuttle Discovery Seat (designed for children aged between six months and four years who have a physical disability)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medifab 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-00951-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-30
  • 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-00951-1
  • 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
    Medifab have identified two safety issues relating to the backrest and the tilt in space locking plunger on shuttle discovery.1. on some discovery seats the rear “s tubes” are moving in and out excessively when the backrest is rocked backwards and forwards. although some movement is normal, there is potential for the s tubes to come out of the mounting block should the motor vehicle used to transport the end user in the discovery buggy be involved in an accident. 2. on some discovery seats the tilt in space plungers are not engaging in the plastic sides. there is potential that the discovery seat may tilt back should the motor vehicle used to transport the end user in the discovery buggy be involved in an accident. there have been no reported incidents in relation to these issues.
  • Acción
    A Technician or Product Consultant will contact customers to arrange a suitable time to carry out the corrective actions. For more details, please see https://www.tga.gov.au/alert/shuttle-discovery-seat . This action has been closed-out on 28/02/2018.

Device

Shuttle Discovery Seat (designed for children aged between six months and four years who have a p...
  • Modelo / Serial
    Shuttle Discovery Seat (designed for children aged between six months and four years who have a physical disability)Product Code: 2006-0010-000Batch #: JS-06-14-DS-**JS-15-14-DS-** JS-18-14-DS-**JS-23-14-DS-**, JS-45-14-DS-**JS-46-14-DS-**ML-8-15-DS-**ML-13-15-DS-**ML-16-15-DS-** ML-17-15-DS-**ML-18-15-DS-**6142761738ARTG #: 160111
  • Manufacturer
    Medifab Ltd

Manufacturer

Medifab Ltd