Events

Retiro De Equipo (Recall) de TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video Systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Trumpf Med Aust 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-01250-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-24
  • 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-01250-1
  • 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
    Trumpf medical has received information stating the iled and trulight lighting systems have fallen from the central axis. the reported incidents occurred while the lights were being positioned for surgical procedures and have been involved in one injury to a user. the investigation of this issue has determinedthe root cause is due to the improper installation of the snap ring that can occur when a spring arm is attached to the central axis. the snap ring is located inside the interface and holds the spring arm in place. if the snap ring is installed improperly, the spring arm of the lighting system can descend over time, and eventually fall from the central axis. when the snap ring has been installed properly, the potential for the lighting system to fall does not exist.
  • Acción
    Hill-Rom is providing users with work around instructions to follow as an interim measure. Hill-Rom will be inspecting affected units and providing additional labelling as a permanent measure.

Device

TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video Systems
  • Modelo / Serial
    TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video SystemsMultiple products and serial numbers affectedARTG Numbers: 200921, 170219 and 170545
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd