Events

Retiro De Equipo (Recall) de Concerto & Basic Shower Trolleys (used for assisted hygiene care)

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-2016-RN-00500-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-28
  • 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-2016-RN-00500-1
  • 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
    As part of post market surveillance (complaint reporting) monitoring, arjohuntleigh received a limited number of complaints where the bolts under the stretcher became loose. there has been one minor injury as a result of a patient falling related to these incidents. arjohuntleigh investigated the issue and concluded the stretcher mounting bolts or stretcher tilting mechanism can become loose which may make the device unstable, providing a potential for risk to the patient or the caregiver. there is a risk the locking mechanism for the stretcher–tilt function may not engage properly, resulting in a patient falling to the floor.
  • Acción
    ArjoHuntLeigh is advising users to ensure the trolleys are checked regularly as per the Instructions for Use (IFU). ArjoHuntLeigh will be performing an inspection on all affected devices to ensure the bolts are securely fastened. This action has been closed-out on 16/02/2017.

Device

Concerto & Basic Shower Trolleys (used for assisted hygiene care)
  • Modelo / Serial
    Concerto & Basic Shower Trolleys (used for assisted hygiene care)Serial Numbers: 3000846870, 3000852015, 3000856697, 3000856697, 3000856697, 3000646121, 3000674706, 3000674706, 3000676859, 3000674706,3000717577, 3000717577, 3000720597, 3000720597, 3000756366, 3000766008, 3000783964, 3000783964, 3000783964 Manufactured between 7 March 2014 and 20 April 2015ARTG Number: 199958
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

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