Events

Retiro De Equipo (Recall) de Ceiling Supply Units (CSU) 80xx/CSU60xx (Used for positioning of medical gas and vacuum 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 Draeger Medical 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-00838-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-16
  • 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-00838-1
  • 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
    The manufacturer has received reports where the drive screw in the motor unit, which lifts and lowers the lower lift arm broke. as a result, the lift arm fell down approximately 60cm (23.6 inches). if the drive screw breaks, personnel standing under the ceiling supply unit (csu) may be injured or objects damaged.
  • Acción
    Draeger will be performing an inspection of affected devices to identify potential fractures of the drive screw during the next maintenance cycle. If a user does not have a service contract with Draeger, an inspection can be commissioned or alternatively, the end user's technical department can carry out the inspection by following the maintenance instructions provided with the recall letter.

Device

Ceiling Supply Units (CSU) 80xx/CSU60xx (Used for positioning of medical gas and vacuum systems)
  • Modelo / Serial
    Ceiling Supply Units (CSU) 80xx/CSU60xx (Used for positioning of medical gas and vacuum systems)ARTG Number: 132260
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd