Events

Retiro De Equipo (Recall) de AvantGuard 1600 Li160A0(Hospital 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 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-00253-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-03-08
  • 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-00253-1
  • 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 reports that the backrest actuator on the avantguard 1600 beds may experience a jolted motion, noise (clanking or chattering), premature wear, or backrest functionality loss when a load is applied to the backrest section. these issues do not affect the cpr functionality in case of emergency.The reported issue is unlikely to cause adverse health consequences.
  • Acción
    Hill-Rom has developed a correction and will contact the affected facilities to modify the affected beds. The CPR function is still operational in case of emergency. For this reason, the device can continue to be used whilst awaiting the correction. If however, the unit experiences a loss of backrest functionality, users are advised to take it out of service and contact Hill-Rom.

Device

AvantGuard 1600 Li160A0(Hospital bed)
  • Modelo / Serial
    AvantGuard 1600 Li160A0(Hospital bed)Models: CS160A0005XXX & PRS160A0005XXXSerial Numbers: HRP001288830 to HRP002497322Manufactured between June 2009 and December 2015.ARTG number: 127268
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd