Events

Retiro De Equipo (Recall) de Volker LTC bed (with lateral release button for the side rails)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Iona Medical Products.

¿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-00835-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-30
  • 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-00835-1
  • 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 received notice that a side rail of a 2080 bed lowered unintentionally and abruptly when a patient leaned over the side rail with his full body weight. hill-rom have evaluated the potential risk and determined a likelihood of occurrence less than 9/100,000 units or 0.009%.Hill-rom would like to remind users of the bed rails of 2080 beds with lateral release buttons for the side rails of the proper use of side rails. if a patient needs to exit the bed, please lower the side rails and not directly load the rail with the full patient weight.
  • Acción
    Hill Rom is advising users to ensure the bed rails are lowered before bed egress or patient assisted during egress of the bed. Hill Rom will be providing a service kit to be installed by a qualified service representative in order to correct the issue.

Device

Volker LTC bed (with lateral release button for the side rails)
  • Modelo / Serial
    Volker LTC bed (with lateral release button for the side rails)Model Number: 2080 FSSerial Number: 2080-2007-51-46ARTG Number: 96733
  • Manufacturer
    Iona Medical Products

Manufacturer

Iona Medical Products