Events

Retiro De Equipo (Recall) de Emergency Room Examination Table

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getinge Australia 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-2018-RN-00653-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-05
  • 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-2018-RN-00653-1
  • 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
    Getinge have received reports where the screws holding the reclining surface on the frame have loosened or completely fallen out. the screws that hold the reclining surface on the frame are not secured against unintentional loosening and the tables may experience this issue with daily use over a number of years. if all screws loosen / become detached and this goes unnoticed, the reclining surface of the table may detach resulting in injury to a patient or operator as a result of falling. to date, no reports of patient injury have been received relating to this issue.
  • Acción
    Getinge are advising they will be in contact with impacted users to replace the screws on the table with new screws secured with detent edge discs.

Device

Emergency Room Examination Table
  • Modelo / Serial
    Emergency Room Examination Table Models: 4203.9602 ARTG number: 163023(Getinge Australia - Table, operation)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA