Urgent Medical Device Correction - Ear Thermometer
OVERHEATING ASSOCIATED WITH THE
BRAUN THERMOSCAN PRO 600 EAR THERMOMETER.
SAFETY ALERT
Author:
Toni Young, MSN, CVAHP
Supply Chain Management
Date:
08/06/2021
HRO PRINCIPALS USED:
Pay Attention to Detail:
when cleaning and using the Braun ThermoScan Pro 600 Thermometer.
Stop – Validate – Verify
before using the
thermometer that the
thermometer is functioning properly and does
not have a blinking green light, require multiple restarts, or if the tip overheats.
NEXT STEPS
:
Please
share this Safety
Alert at your Safety
Huddles and
Department
meetings.
Please post and
follow proper
cleaning procedure,
attached.
SITUATION:
There is a potential risk associated with overheating the
Braun ThermoScan PRO 6000 probe tip due to fluid ingress. 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 to the ear canal of the patient.
BACKGROUND
:
Hillrom has received 116 reports of complaints regarding
overheating of the Braun ThermoScan 6000 probe tip out of more than
1.1 million units sold. To date, they are aware of ONE reported injury
associated with this issue.
ASSESSMENT:
1.
Use the correct cleaning procedure for the device.
2.
Inform Users of the potential safety risk of inappropriate cleaning
3.
Inform users of what visual signals to look for to minimize the potential to
overheating probe tips.
RECOMMENDATION:
1.
Share this communication with all potential users and provide the cleaning
guide for proper cleaning.
2.
Contact Supply Chain if the following occurs:
a.
Do not use the device if the ring around the measurement button
shows a green blinking or flashing light instead of a “ready state”
(solid green light).
b.
Do not use the device if the device requires multiple power-ups prior
to going to the “ready state” (solid green light).
c.
If you experience an overheating probe tip, do not use the device.
Содержание Braun ThermoScan PRO 6000
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