Events

Retiro De Equipo (Recall) de Liko Universal SlingBar 350, SlingBar 450 and SlingBar 600 (used with Golvo, Uno, LikoLight, Likorall, Multirall and Viking XS/S/M/L mobile patient lifts)

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-00082-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-21
  • 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-00082-1
  • 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 safety issue related to the universal slingbar 350, slingbar 450 and slingbar 600 which can be attached to various liko overhead and mobile patient lifts,complaints have been received that the centre bolt of this sling bar, which connects the bar to the patient lift, has failed during use.The potentially affected sling bars have been produced until may 2014.Analysis has shown that the sling bar is reliable when used as intended with the sling bar level during the lift. however, if the sling bar is not used as intended, the bolt may be weakened. if the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. this hazard could cause potentially minor to catastrophic injuries to a patient.
  • Acción
    Hill-Rom is providing users with a set of instructions to follow to identify if they have an affected sling bar. This inspection should be carried out at regular intervals. Hill-Rom is providing a replacement sling bar to users who have an affected sling bar free of charge. This action has been closed on 26/05/2017.

Device

Liko Universal SlingBar 350, SlingBar 450 and SlingBar 600 (used with Golvo, Uno, LikoLight, Liko...
  • Modelo / Serial
    Liko Universal SlingBar 350, SlingBar 450 and SlingBar 600 (used with Golvo, Uno, LikoLight, Likorall, Multirall and Viking XS/S/M/L mobile patient lifts)Universal SlingBar 350Part Numbers: 3156074, 3156084 and 3156094Universal SlingBar 450Part Numbers: 3156075, 3156085 and 3156095Universal SlingBar 600Part Numbers: 3156076 and 3156086Serial Numbers: 1200101 to 1370151ARTG Number: 188199
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd