Events

Retiro De Equipo (Recall) de GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor

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-00906-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-07-06
  • 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-00906-1
  • 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 identified an issue which may result in a lack of drying/storage of restrictive endoscopes when they are placed in the eds8. this potential for malfunction is caused by a device design issue. it is identified that the delivered pressure and flow rate of the eds8 compressor is too low. under certain conditions (drying/storage of a restrictive endoscope), the compressor may not be powerful enough to reach the 5l/min airflow required to properly dry/store the endoscopes.Getinge have received several complaints related to this issue, but there was no reported user or patient injury.
  • Acción
    Getinge have developed a compressor with a higher flowrate to correct this issue. Getinge will contact users to arrange replacement of the current compressor.

Device

GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor
  • Modelo / Serial
    GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor Model Numbers: 01039717 – Right hinge EDS8-R and 01039716 – Left hinge EDS8-L ARTG Number: 276061(Getinge Australia Pty Ltd - Endoscope drying/storage chamber)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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