Events

Retiro De Equipo (Recall) de Compella Bariatric Bed System, Controllers and Air Surfaces

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Hill-Rom 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-2016-RN-00745-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-08
  • 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-2016-RN-00745-1
  • 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
    Hill-rom has become aware of a potential issue with some compella air supply units and air surfaces. the compella air supply unit has been prone to inadequate pressure, which prevents the surface from achieving required settings for weight-based pressure redistribution. this also prevents the low air loss feature from operating. in addition, within the low air loss surface, a hose in the foot section is prone to kinking, which can impact airflow to the topper and prevent the proper adjustment of the air bladders to relieve pressure.
  • Acción
    A Hill-Rom representative will be contacting affected facilities to make arrangements for updating the affected capital Compella Air Supply Units and air surfaces. In the interim, Hill-Rom recommends customers to continue to use the product as they normally would. The mattress system will provide an alarm in the event the Compella Air Supply Unit or Air Surface does not operate properly. This action has been closed-out on 18/05/2017.

Device

Compella Bariatric Bed System, Controllers and Air Surfaces
  • Modelo / Serial
    Compella Bariatric Bed System, Controllers and Air SurfacesModel Number: P7800ACompella ControllersProduct Number: P7810AManufactured between 25 March 2015 to 11 December 2015Compella Air SurfacesProduct Number: P642AManufactured between 25 March 2015 to 25 September 2015ARTG Numbers: 239273, 239274
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd