Events

Rappel de Bunnell Life Pulse Patient Circuits (Used with Life Pulse High Frequency Ventilator) Manufactured after 19-12-2012

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

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-2012-RN-01190-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-01-04
  • 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-2012-RN-01190-1
  • 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
    The heater wire insulation can melt, causing a short which creates sparking and smoke close to the humidifier cartridge.
  • Action
    Unaffected replacement circuits are not available at this time. Each user should consider the likelihood and severity of the potential risks of using the affected circuits, as well as the medical necessity of using High Frequency “Jet” Ventilation, to determine whether it would be in their patients’ best interests to use the affected circuits or not. If users have other options for High Frequency “Jet” Ventilation, the affected units can be returned to AHC Solutions for credit to be issued.

Device

Bunnell Life Pulse Patient Circuits (Used with Life Pulse High Frequency Ventilator) Manufactured...
  • Modèle / numéro de série
    Bunnell Life Pulse Patient Circuits (Used with Life Pulse High Frequency Ventilator) Manufactured after 19-12-2012 Lot Numbers: 12C092, 12E211, 12H330, 12C102, 12E224, 12H349, 12C115, 12F241, 12I362, 12C125, 12F254, 12I371, 12C136, 12F271, 12I397, 12D159, 12G279, 12J413, 12D172, 12G290, 12J430, 12D189, 12G307, 12J448, 12E204, 12G321, 12K457, 12K471ARTG number for the Ventilator: 179402
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd