Events

Rappel de Renasys GO External Power Supply Units supplied with Renasys GO NPWT Pumps (Negative Pressure Wound Therapy System)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smith & Nephew 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-2016-RN-00283-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-15
  • 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-2016-RN-00283-2
  • 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
    Smith & nephew pty ltd. has identified a risk that some external power units have the potential to overheat and induce an electric shock whilst in use with the renasys go npwt pump. only certain external power units are affected by this issue. to date there have been 2 reported adverse events related to this issue, including one electric shock – discomfort, and one minor burn.
  • Action
    Smith & Nephew is advising users to disconnect all affected power units from the mains electrical supply and switch to an unaffected power unit. The pump will continue to provide treatment as the device will run off its internal battery during this time. Affected units can be returned to Smith & Nephew and will be replaced with unaffected stock.

Device

Renasys GO External Power Supply Units supplied with Renasys GO NPWT Pumps (Negative Pressure Wou...
  • Modèle / numéro de série
    Renasys GO External Power Supply Units supplied with Renasys GO NPWT Pumps (Negative Pressure Wound Therapy System)Renasys GO External Power UnitPart Number: 66800161 Serial Numbers below 144500875ARTG Number: 155594
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd