Events

Rappel de Dräger Babytherm Infant Warmer

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 Medical 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-2016-RN-00794-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-06-15
  • 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-00794-1
  • 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
    Dräger has become aware of a case in which a babytherm 8004 without patient was operated in skin temperature mode with skin temperature sensor to prepare it for use. ln skin temperature mode, the radiant warmer output is controlled automatically until the set skin temperature is reached. as a result of operating the temperature sensor without patient contact, the radiant warmer was operated continuously at a high output ievel. during this forced continuous operation under high thermal ioad, the heater element aged faster. a part became detached from the heater element and fell onto the mattress tray where a towel caught fire. dräger's investigation revealed that the instructions for use do not contain explicit hints/warnings that refer to this misuse. additionally, dräger's analyses have shown that the heater elements are not replaced at regular intervals as recommended in the babytherm instructions for use.
  • Action
    Dräger has amended the Instructions for Use Manual for new devices, and is providing users with a supplement which contains additional warnings and following additional instructions: - Do not operate the device in skin temperature mode with temperature sensor without patient contact - lf the heating elements have been in operation for more than 2 years, please replace them. Customers are advised to distribute the notice to all departments with the Babytherm Infant Warmer; models 8004; and/or 8010 within their facility. This action has been closed-out on 20/02/2017.

Device

Dräger Babytherm Infant Warmer

Manufacturer

Draeger Medical Australia Pty Ltd