Events

Retiro De Equipo (Recall) de Aegis Standing Sling - Lift, patient transfer, sling/harness/strap

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

¿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-2015-RN-00308-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-02
  • 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-2015-RN-00308-1
  • 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
    During the use of the device it was noticed by the healthcare professional that the stitching on one of the loops holding the sling to the spreader bar of the hoist had come loose. no harm came to the patient or the healthcare worker. the stitching had become loose after more than twelve months use due to either wear or inadequate back stitching and could have been exacerbated if the operator had incorrectly twisted the loop when attaching it to the spreader bar.
  • Acción
    Solaris Medical is contact end users through the distributors to advise of the potential issue. Solaris Medical will inspect all potentially affected units and repair if damaged. This action has been closed-out on 15/08/2016.

Device

Aegis Standing Sling - Lift, patient transfer, sling/harness/strap
  • Modelo / Serial
    Aegis Standing Sling - Lift, patient transfer, sling/harness/strapARTG Number: 203097
  • Manufacturer
    Solari Medical

Manufacturer

Solari Medical
  • Source
    DHTGA