Events

Retiro De Equipo (Recall) de Enterprise 8000 Electrical Bed

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Arjo 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-2018-RN-00105-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-02-21
  • 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-2018-RN-00105-1
  • 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 become aware of the potential for loose brake pedal screws (part number s1306) which are responsible for connecting the brake pedal with the base frame of the bed and keeping the brake in the correct position. this issue of loose screws is visible to users. there is no evidence to suggest that this anomaly is related with any potential risk to users.
  • Acción
    Arjo is advising users to inspect the beds to determine if the screws are loose on the brake mechanism. If users see that the screw is not tightened fully, it means thatthe device is affected by this correction. Check the castor operation, paying attention to steering and/or braking function. If users detect small movements between the parts and loose movement between braking system, it means the device may be affected by this correction. Arjo will be inspecting the affected devices and replacing the affected screws during the next service visit. Users that undertake serving of their own devices are advised to unscrew the old screw S1306 and replace with new one, by use the torque wrench with 10.2 Nm torque.

Device

Enterprise 8000 Electrical Bed
  • Modelo / Serial
    Enterprise 8000 Electrical BedModel Numbers: 5000, 8000, 9000, E5000X, E8000X, E9000XARTG Number: 283224(Arjo Australia - Bed, general-purpose, electrical)
  • Manufacturer
    Arjo Australia Pty Ltd

Manufacturer

Arjo Australia Pty Ltd
  • Source
    DHTGA