Events

Rappel de Edwards Lifesciences Heart Reference Sensor

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Edwards Lifesciences 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-00503-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-06-17
  • 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-00503-1
  • 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
    A component of the clearsight system can be damaged if not handled properly. the heart reference sensor (model number evhrs) compensates for pressure differences between the finger cuff and the heart. the finger component of the evhrs may be damaged if subjected to moderate to significant surface impact.
  • Action
    Edwards Lifesciences is providing work around instructions to assist end users in determining whether the Heart Reference Sensor has been damaged. An insert, included with the recall letter, will be provided with all new EVHRS devices and the Operating Manual of the EV1000NI will be updated on its next release. Edwards Lifesciences is currently working on design changes to avoid the potential for damage to the device and to detect whether damage has been sustained during use. This action has been closed-out on 11/08/2016.

Device

Edwards Lifesciences Heart Reference Sensor

Manufacturer

Edwards Lifesciences Pty Ltd