Urgent Medical Device Correction FA-2021-05-001-SKF-004 Potential risk of probe tip overheating associated with Welch Allyn® Braun® ThermoScan® PRO 6000 Ear Thermometer.

 

Affected Medical Device : WELCH ALLYN BRAUN THERMOSCAN EAR THERMOMETER PRO6000

 

MDA Reference Number : MDA/FCA/2021-P120

 

MDA Registration Number : GB57417827518

 

Decription : Alleging that the speculum tip on the Braun PRO 6000 was over heating. An investigation into the root cause of the speculum tip overheating determined that fluid ingress is causing the sensor to behave inconsistently, which ultimately does not allow the built-in safety mitigation to work correctly.

 

Local Establishment Contact Detail :

Kah Syuan LEE
Senior Specialist, QA/RA
ASEANNA
GF101-2, TOWER 2, WISMA AMFIRST, SS7/15, 47301 PETALING JAYA, SELANGOR

Email : KahSyuan.Lee@hillrom.com

 

 A copy of FSN.