Events

Retiro De Equipo (Recall) de ClinActiv and ClinActiv Plus Therapy Surface (used to provide pressure relief to aid in the prevention and treatment of pressure ulcers)

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-2013-RN-01108-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-04
  • 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-01108-1
  • 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 possible hazardous situation when silicon oil contained in the vario sensor within the clinactiv therapy surface is accidentally released. when the pocket of silicone oil is subjected to excessive mechanical stress, it may disconnect and leak oil outside the mattress enclosure and onto the floor.
  • Acción
    Hill-Rom is providing additional cleaning instructions on cleaning silicon oil from affected surfaces, and advising users to ensure the Vario sensor is replaced every 3 years. This action has been close-out on 11/02/2016.

Device

ClinActiv and ClinActiv Plus Therapy Surface (used to provide pressure relief to aid in the preve...
  • Modelo / Serial
    ClinActiv and ClinActiv Plus Therapy Surface (used to provide pressure relief to aid in the prevention and treatment of pressure ulcers)Model Number: N02050, N02051, P02062, P02063, P02064, P02065All Serial Numbers affectedARTG Number: 130272
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd