Events

Recall of Babytherm 8004/8010 and Babytherm 8000WB for newborns (Infant warmers and open infant care units)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger Medical Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-00961-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-09-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00961-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Dräger have become aware of a case in which a side panel on a babytherm 8010 did not fully slide to the bottom in the corner guide and was not completely locked. the side panel did not open during this incident and no patient was affected. as part of the review, dräger identified that the inner 70mm panels were not always used however, the inner 70mm panels are part of the safety concept of the babytherm 80xx. if contrary to the information provided in the instructions for use manual the inner panels are not inserted and if a side panel has not been fully locked into position this may allow the baby’s movements to open the side panel. it may be possible for a child to fall out.
  • Action
    Users are reminded to pay attention to the information provided in the Instruction for Use Manual: i.e., “Check that the side panels lock securely into position and that they remain securely locked”. If the locking mechanism is not functioning or the inner panels are missing or damaged, please contact Dräger Customer Service to arrange correction. This action has been closed-out on03/02/2017.

Device

Babytherm 8004/8010 and Babytherm 8000WB for newborns (Infant warmers and open infant care units)
  • Model / Serial
    Babytherm 8004/8010 and Babytherm 8000WB for newborns (Infant warmers and open infant care units)ARTG Number: 121161
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd