WGT3X-BT

Description of Event or Problem

ON (B)(6) 2025, A CUSTOMER REPORTED A WGT3X-BT DEVICE BECAME "UNCOMFORTABLY HOT TO THE TOUCH" WHILE IT WAS CONNECTED TO A PC VIA USB AND CHARGING. THIS IS THE SECOND DEVICE THIS CUSTOMER REPORTED AS BECOMING "HOT", AND THAT IS A SEPARATE REPORT. THE CUSTOMER CONFIRMED THE FOLLOWING USAGE CONDITIONS: CHARGING AND DATA READING WERE PERFORMED USING USB 2.0 CABLES. THE DEVICE WAS CONNECTED TO A PC VIA A SUPERSPEED USB 3.0 HUB. THE REPORTED CONDITION OCCURRED WHILE THE DEVICE WAS ACTIVELY CONNECTED TO THE PC. ACTIGRAPH REQUESTED THE DEVICE BE RETURNED FOR INVESTIGATION. ON (B)(6) 2025, EVALUATION WAS CONDUCTED VIA A CONTROLLED CHARGING TEST USING A MANUFACTURER-SUPPLIED USB 2.0 CABLE, DURING WHICH THE DEVICE'S TEMPERATURE ROSE FROM 22.5°C TO A PEAK OF 30.7°C BEFORE STABILIZING AT 29.0°C AFTER REACHING FULL CHARGE. THE REPORTED CONDITION COULD NOT BE REPRODUCED. NO OVERHEATING WAS OBSERVED, AND NO INTERNAL NON-CONFORMITIES. WERE FOUND UPON DISASSEMBLY. ALL DATA WAS RECORDED USING CALIBRATED EQUIPMENT AND STORED FOR REFERENCE. NO SPECIFIC CLINICAL SYMPTOMS OR INJURIES WERE REPORTED BY THE CUSTOMER. HOWEVER, THE CUSTOMER EXPRESSED CONCERN ABOUT THE POTENTIAL FOR BURNS DUE TO THE DEVICE BECOMING UNCOMFORTABLY HOT TO THE TOUCH. NO SERIOUS OUTCOME WAS REPORTED. THERE WAS NO INDICATION OF INJURY, HOSPITALIZATION, OR MEDICAL INTERVENTION. THE CUSTOMER'S ACTION TO STOP USING THE DEVICE WAS PRECAUTIONARY. THE INCIDENT DID NOT RESULT IN PERMANENT DAMAGE, DISABILITY, OR INDIRECT HARM. WHILE THIS IS THE SECOND REPORT FROM THE SAME CUSTOMER, ACTIGRAPH HAS NOT IDENTIFIED A SYSTEMIC ISSUE OR NEW RISK ASSOCIATED WITH THIS DEVICE, OR SIMILAR MODELS. THE INCIDENT APPEARS TO BE ISOLATED AND POTENTIALLY INFLUENCED BY ENVIRONMENTAL OR USAGE CONDITIONS, SUCH AS SIMULTANEOUS CHARGING AND DATA TRANSFER VIA A HIGH-SPEED USB HUB. BASED ON THE AVAILABLE EVIDENCE AND HISTORICAL PERFORMANCE DATA, ACTIGRAPH CONCLUDES THAT THERE IS NO INDICATION OF A NEW OR INCREASED RISK ASSOCIATED WITH THE REPORTED ISSUE. HOWEVER, IN THE INTEREST OF CONTINUED VIGILANCE AND TRANSPARENCY, ACTIGRAPH SUBMITTED THE EU MIR (REPORT NUMBER (B)(4)) AND IS SUBMITTING THIS FDA 3500 VOLUNTARILY IN AN EFFORT TO REMAIN VIGILANT AND TRANSPARENT. ACTIGRAPH WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE WGT3X-BT DEVICE HAS RISK CONTROLS IN PLACE AS FOLLOWS: -- THE WGT3X-BT DEVICE HAS BEEN TESTED TO IEC 60601-1 STANDARD - "GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE." -- WARNING SYMBOL ON DEVICE AND EXPLAINED IN USER'S MANUAL -- FAIL-SAFE FUNCTIONS USED -- INHERENTLY SAFE DESIGN -- UL APPROVED MATERIALS -- HIGH UL FLAMMABILITY RATED MATERIALS USED -- UL APPROVED BATTER -- BATTERY SAFETY CIRCUIT -- STRATEGIC USE OF REDUNDANCY WITH ELECTRONIC COMPONENTS THAT PROVIDE ALTERNATIVE FUNCTIONAL CHANNELS IN CASE OF FAILURE -- PERFORMANCE OF QUALITY INSPECTION -- IPX7 RATED.