Field Safety Notice Welch Allyn Braun ThermoScan PRO 6000 (ICN 1854)
Important Customer Notice Field Safety Notice
Ref: 2022/1854 ICN Number: 1854
NHS Supply Chain Reference: 45
- Welch Allyn Inc. (a Hillrom company) has issued a Field Safety Notice to advise of the potential risk associated with overheating of the Braun ThermoScan PRO 6000 probe tip due to fluid ingress. This issue potentially impacts all PRO 6000 thermometers in the field.
- If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient. Population at greatest risk are patients that are unable to communicate or react to heat exposure.
- The Field Safety Notice has been issued to remind users of the correct cleaning procedures for the device. Hillrom is including a Cleaning Guide which summarises the correct cleaning protocol to minimise potential for liquid ingress.
- Two of the affected products are supplied via NHS Supply Chain:
- Hillrom has updated the Braun ThermoScan Pro 6000 Instructions for Use (IFU) to include additional fluid ingress warnings.
|NPC||Product Description||Supplier Code / MPC||Route|
|FWH157||Thermometer Tympanic Device Pro 6000 with small cradle||06000 200||Blue Diamond|
|FWH158||Thermometer Tympanic Device Pro 6000 with large cradle||06000 300||Blue Diamond|
- Inform users of the potential safety risk of inappropriate cleaning practices.
- Inform users of what visual signals to look for to minimise the potential exposure to overheating probe tips.
- Read and follow the full instructions in the Field Corrective Notice, share with all users of the affected products and instruct them to follow the Updated Cleaning Guide for correct cleaning.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or Customer Relationship Manager.