Events

Retiro De Equipo (Recall) de Standard SlingBar 450Distributed between January 1980 and November 2012

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-00477-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-09
  • 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-00477-1
  • 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 safety issue related to the standard slingbar 450, which could be attached to various liko overhead and mobile lifts. a serious injury to a patient, caregiver, or bystander could result from tripping or otherwise falling in to the slingbar, typically while the lift is parked or stored when not in use. the sling hook on the other end of the sling bar could pierce a body structure such as the head, shoulder, or groin.
  • Acción
    Hill-Rom is providing customers with a sling-bar safety cover to mitigate the risk of patient or user injury. For more details, please see http://www.tga.gov.au/safety/alerts-device-standard-slingbar-450-131001.htm .

Device

Standard SlingBar 450Distributed between January 1980 and November 2012
  • Modelo / Serial
    Standard SlingBar 450Distributed between January 1980 and November 2012Product numbers: 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043 & 5019013These product numbers may be bundled with the Golvo 1000, 3000 and 7000 series lifts, Viking M, Viking L, LikoLight 100 and 125, Caroli 101, and Uno 100, 101 and 102ARTG Number: 188199
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd