Ogos 2021 : 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.
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 : [email protected]
