Events

Retiro De Equipo (Recall) de BariAir Therapy System (Provides low air-loss pressure management therapy, pulsation, percussion, turn-assist, flexible patient positioning capabilities and built-in scales for large patients)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ARJO Hospital Equipment Pty Limited.

¿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-2013-RN-00398-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-03
  • 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-2013-RN-00398-1
  • 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
    There have been reports of patients inadvertently placing the system into a pseudo-exit position when using the hand control pendant.
  • Acción
    Customers are requested to remove the hand pendant from use on all BariAir Therapy Systems. If removal of the hand pendant is not possible it is recommended that patient positioning is regularly inspected. A new hand pendant has been developed. ArjoHuntleigh will contact their customers to coordinate the replacement of the hand pendant.

Device

BariAir Therapy System (Provides low air-loss pressure management therapy, pulsation, percussion,...
  • Modelo / Serial
    BariAir Therapy System (Provides low air-loss pressure management therapy, pulsation, percussion, turn-assist, flexible patient positioning capabilities and built-in scales for large patients)Model Number: 404000Affected Serial Numbers: BKIK00570, BKIK00565 and BKIK00563Supplied previously in Australia by KCI Medical Australia Pty Ltd under ARTG# 176118
  • Manufacturer
    ARJO Hospital Equipment Pty Limited

Manufacturer

ARJO Hospital Equipment Pty Limited
  • Source
    DHTGA