Events

Retiro De Equipo (Recall) de GETINGE WD15 Claro - Washer Disinfector

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-00829-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-27
  • 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-00829-1
  • 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 a possible water leakage on limited washer disinfectors of model type wd15. if this issue occurs, both an acoustic and visual alarm ("a03 over flow co" on the machines display) will be present. this leakage may take place during operation in the last part of the cleaning and disinfection cycle. the leaking water has not been processed through the machine and from investigations it does not make contact with critical electrical components of the washer.If the issue is left unattended, there can be a leakage of cold water out from the water supply to the machine (up to 2 l/min). if users do not respond to the alarm, there may be a significant amount of water on the floor which may result in a person falling and acquiring an injury. there is also a risk for property damage from the water leak.To date, no injuries have been reported as a result of this issue.
  • Acción
    Getinge are advising they are investigating this issue and will provide a solution as soon as it becomes available. In the interim, users may continue to use the washer, provided that the machine is not left unattended. Users should react to device alarms immediately. If an alarm *A03 OVER FLOW CO* is activated, users are advised to do the following; 1. Switch off the main switch; 2. Close shut off valves in the water supply lines; and 3. Contact a service technician.

Device

GETINGE WD15 Claro - Washer Disinfector
  • Modelo / Serial
    GETINGE WD15 Claro - Washer DisinfectorSerial Numbers: WAA083548 and WAA082736ARTG Number: 125655(Getinge Australia Pty Ltd - Washer, decontamination, utensil)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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