Events

Retiro De Equipo (Recall) de Contoura 380 and 480 Bed Manufactured between 12 January 2011 to 31 December 2011

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Huntleigh Healthcare 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-00762-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-24
  • 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-2013-RN-00762-1
  • 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
    During investigations by arjohuntleigh it has been determined that the din connector used on these beds has been compromised during the cable manufacturing process. the supplier has determined that liquid droplets have been found inside the male din connector. this substance has been identified as phosphorous that is leaching from the black plastic flame reduction material used in the din connector. the effects of this can lead to a high resistance (ohm) connection between the pins and could result in the beds performing uncommanded movements.
  • Acción
    Customers are requested to remove beds from use and contact the ArjoHuntleigh Service Line immediately if at any time a Contoura 380 or 480 bed performs uncommanded movement. An ArjoHuntleigh Technician will attend each facility to replace any defective DIN connectors. DIN Connectors with production batch date of October or November 2010 will need to be replaced. DIN Connectors with production batch date of January 2011 and February 2011 will undergo a Megger test which will determine if the connector needs to be replaced. This action has been closed-out on 19/05/2016.

Device

Contoura 380 and 480 Bed Manufactured between 12 January 2011 to 31 December 2011
  • Modelo / Serial
    Contoura 380 and 480 Bed Manufactured between 12 January 2011 to 31 December 2011ARTG Number: 205117
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA