Events

Rappel de Dräger Jaundice Meters

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Draeger Australia 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-2018-RN-00325-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-24
  • 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-2018-RN-00325-1
  • 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
    Draeger has determined through post market surveillance activities that some users have concerns about the method used by the jm-103 and jm-105 to indicate that a taken measurement is out of range (higher than the measuring range of the device). uncertainty about high value indication may result in delayed treatment of a patient with hyperbilirubinemia.As described in the instructions for use manual and in the device's training materials:- jaundice meter model jm-103 displays a blinking "- - -" when the measurement is out of range. the measuring range is defined to 340 µmol/l; and - jaundice meter model jm-105 displays a blinking "- 0 -" when the measurement is out of range. the measuring range is defined to 340 µmol/l.
  • Action
    Draeger is providing users with stickers to adhere to JM-103 and JM-105 devices to re-enforce the meaning of the associated blinking units "---" for JM-103 and "-0-" for JM-105 when the measurement is higher than the measuring range of the device. Users are to refer to the instructions provided on the Customer Letter for correct location for the stickers.

Device

Dräger Jaundice Meters
  • Modèle / numéro de série
    Dräger Jaundice MetersModels Numbers: JM-103 and JM-105 ARTG Number: 152624Draeger Australia - Analyser, bilirubinometer
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd