Events

Retiro De Equipo (Recall) de C-series carry bars (used with C300, C450 Manual, C625 ceiling lifts/hoists)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Rehab Assist 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-01200-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-14
  • 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-01200-1
  • 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
    Some c-series carry bars are attached to the track using a plastic swivel. if the plastic swivel in these bars becomes damaged there is the potential for it to separate from the carry bar, resulting in a patient fall. rehab assist will supply a free metal insert to be placed inside affected carry bars to prevent separation if the plastic swivel becomes damaged.There have been nine incidents worldwide in which the plastic swivel mechanism has been reported as damaged. no incidents have been reported in australia and there have been no injuries reported as a result of this issue.
  • Acción
    Rehab Assist is advising distributors to contact all end users and inspect the swivels to determine if there are any damaged swivels in use. Customers are advised to inspect the swivel for damage or contact their distributor to arrange for a technician to do an inspection. If there is no damage the lift can continue to be used as normal. The metal insert should be installed as soon as practicable. If the swivel appears damaged, do not use the lift until the metal insert has been inserted. Wherever the plastic swivel is damaged, users are also advised to purchase and replace the carry bar as soon as possible. For more details, please see https://www.tga.gov.au/alert/rehab-assist-c-series-ceiling-hoists .

Device

C-series carry bars (used with C300, C450 Manual, C625 ceiling lifts/hoists)
  • Modelo / Serial
    C-series carry bars (used with C300, C450 Manual, C625 ceiling lifts/hoists)Models Affected: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, 360757 (identifiable by a black plastic swivel/puck)ARTG Number: 169639
  • Manufacturer
    Rehab Assist Pty Ltd

Manufacturer

Rehab Assist Pty Ltd