Events

Retiro De Equipo (Recall) de ArjoHuntleigh Flowtron ACS900 Active Compression System Flowtron ACS900 pumps manufactured between 26 Sept 2014 and 20 Dec 2016 with software V1.099

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Huntleigh Healthcare 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-00786-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-06-26
  • 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-00786-1
  • 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
    Arjohuntleigh has identified that in some instances specific acs900 pumps will constantly deliver pressure to the garment without triggering the alarm. an investigation has concluded that the consistent flow of pressure to the garment without deflation may lead to a potential risk of injury to patients. arjohuntleigh has received a limited number of complaints regarding this specific state.
  • Acción
    ArjoHuntleigh is requesting that customers: 1. Ensure that all caregivers and users of the ArjoHuntleigh Flowtron ACS900 pump are made aware of this recall for product correction and that all listed devices at their facility are available to be upgraded during the service technician visit; 2. Complete, sign and return the Customer Response Form to ArjoHuntleigh. Note: ArjoHuntleigh will contact the designated facility representative listed on the Customer Response Form to schedule service to upgrade the software on all listed devices, free of charge.

Device

ArjoHuntleigh Flowtron ACS900 Active Compression System Flowtron ACS900 pumps manufactured betwee...
  • Modelo / Serial
    ArjoHuntleigh Flowtron ACS900 Active Compression SystemFlowtron ACS900 pumps manufactured between 26 Sept 2014 and 20 Dec 2016 with software V1.099Serial Number range: 1400028031 to 1600048470ARTG Number: 254916
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

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