| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00794-1 |
| Product Name/Description |
Dräger Babytherm Infant Warmer
Model Numbers: 8004 and 8010
Multiple serial numbers affected
ARTG number: 115160 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
03 9244 7248 – Draeger Medical Australia |