Events

Retiro De Equipo (Recall) de Liko Multirall 200 overhead lift and S65 Carriage

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-2017-RN-01289-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-18
  • 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-2017-RN-01289-1
  • 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 user-error of improper attachment of the multirall 200 overhead lift to the s65 carriage that could result in a potential safety issue. since the introduction of this combination in 2007, twenty six events have been reported where an improper connection of the s65 carriage to the multirall 200 overhead lift was not identified by the user prior to use and a disconnect occurred, resulting in the unit falling. eleven of these cases have alleged injuries to the caregiver or patient.Hill-rom would like to reinforce that the instructions relating to proper connection, including verification of proper attachment prior to use, must be followed when attaching the multirall 200 overhead lift to the s65 carriage. the instructions for proper connection are included in the instruction guide provided with the liko multirall 200 overhead lift and s65 carriage.
  • Acción
    Hill-Rom is advising users to refer to the instructions for use and additional Quick Reference Guide to aid in correct installation of the Multirall 200 overhead lift to the S65 carriage. The Quick Reference Guide also provides a link to a video that users should view for system installation/use.

Device

Liko Multirall 200 overhead lift and S65 Carriage
  • Modelo / Serial
    Liko Multirall 200 overhead lift and S65 CarriageMultirall 200 overhead lift Product Number: 3130001S65 CarriageProduct Number: 3136011All Serial NumbersARTG Number: 161863
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd