Events

Rappel de Single Limb Circuit for Pneupac Ventilators, with PEEP Valve

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smiths Medical Australasia 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-2015-RN-00047-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-01-19
  • 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-2015-RN-00047-1
  • 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
    Certain single limb circuits were labelled as “mr conditional” but contained peep valves that should have been labelled as “mr unsafe”.If the affected products are used in an mr environment, there is a potential for the peep valve to become dislodged during the mri procedure. the effect of a reduction of peep pressure could be a reduction in oxygen saturation of the blood which would be detectable by clinical observation of signs and symptoms and through oximetry. also there is the potential for the affected products to create artifacts in the mri scan; however, these artifacts would be highly detectable by the clinician reading the mri.
  • Action
    Facilities that use the Single Limb Circuit in the MRI suite are requested to quarantine the affected devices. A Smiths Medical representative will arrange for the exchange of unused affected product. This action has been closed-out on 08/08/2016.

Device

Single Limb Circuit for Pneupac Ventilators, with PEEP Valve
  • Modèle / numéro de série
    Single Limb Circuit for Pneupac Ventilators, with PEEP ValveOrder code:100/905/301 Batch numbers: 121105, 130128, 130225, 130408, 130624, 131209, 140217, 140407, 140428 & 140616 Order code:100/905/302Batch numbers: 120229, 120326, 120402, 120507, 120716, 120820, 130318, 130520, 130819, 131007, 131125, 131216, 140526, 140707 & 140714 ARTG number: 109570
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd