Events

Retiro De Equipo (Recall) de Getinge HS33 Sterilsers

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-2017-RN-00251-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-28
  • 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-2017-RN-00251-1
  • 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 has identified an issue with getinge hs33 manual door sterilisers, which can potentially cause the door with manual mechanism to unseal during the process. this can cause potential steam leakage. this potential for malfunction is caused by the design of the door hook which is a part of the door locking mechanism (part number 4839900). when the door has been closed and the sterilisation process has started, the leak may occur through the door gap, however the door will not slide down as the clamping brakes located on both sides of the door hinder the slide down. in case the process must be interrupted due to safety reasons, the emergency stop button will immediately cut off steam supply to the chamber. getinge's investigation which included risk analysis and evaluation of the worst-case scenario concluded that it is highly unlikely the malfunction would cause or contribute to an injury.
  • Acción
    Getinge has developed a new design of the component (part no 6011000223) to prevent device door to unseal during the process. This action is to replace the existing door hook (part no 4839900) with the new and corrected design.

Device

Getinge HS33 Sterilsers
  • Modelo / Serial
    Getinge HS33 SterilsersModel Numbers: 978053XXX, 978055XXX and 6011978043XXXSerial Numbers: 11101581, 12031135, 12171741, 12481961, 13122119, 13402211, 13412218, 13412224, 13452238, 14483126ARTG Number: 275198
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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