Events

Rappel 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)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par ARJO Hospital Equipment Pty Limited.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00398-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-03
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00398-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    There have been reports of patients inadvertently placing the system into a pseudo-exit position when using the hand control pendant.
  • Action
    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,...
  • Modèle / numéro de série
    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