WGT3X-BT

Description of Event or Problem

ON (B)(6) 2025, A USER REPORTED TO ACTIGRAPH THAT THE WGT3X-BT DEVICE "BECAME HOT" WHILE WEARING. THE REPORT STATED THAT ON THE FIFTH NIGHT OF USE, THE SUBJECT "FELT PAIN AND REMOVED THE DEVICE IMMEDIATELY." FOLLOWING PROCEDURES FOR COMPLAINT HANDLING, ACTIGRAPH ASKED FOLLOW-UP QUESTIONS AND DETERMINED THE SUBJECT DID NOT SEEK MEDICAL HELP AND NO INJURIES OCCURRED. FOLLOWING A COMPREHENSIVE INVESTIGATION, ACTIGRAPH DETERMINED THAT THE REPORTED OVERHEATING OF DEVICE (B)(6) WAS MOST LIKELY CAUSED BY A SHORT CIRCUIT ON THE PRINTED CIRCUIT BOARD (PCB), RESULTING FROM WATER INTRUSION. ACTIGRAPH REQUESTED TO HAVE THE DEVICE RETURNED FOR INVESTIGATION. THE DEVICE WAS NON-FUNCTIONAL, AND VISUAL INSPECTION REVEALED HAZING ON THE HOUSING AND SIGNIFICANT CORROSION ON MULTIPLE PCB COMPONENTS. FURTHER DISASSEMBLY CONFIRMED THE PRESENCE OF WATER BETWEEN THE BATTERY AND PCB CONNECTORS, AND LOCALIZED MELTING OF THE BATTERY WIRE CONNECTOR. THE ROOT CAUSE ANALYSIS CONCLUDED THAT WATER LIKELY ENTERED THE DEVICE DUE TO THE USB CAP NOT BEING FULLY FASTENED, DESPITE THE DEVICE BEING PROPERLY ASSEMBLED AND SHOWING NO STRUCTURAL DEFECTS. THE DEVICE IS RATED TO IPX7 WHEN THE INSTRUCTIONS FOR USE (IFU) ARE FOLLOWED; WITH THE USB SECURED. THE BATTERY SAFETY CIRCUIT FUNCTIONED AS INTENDED, AND THE BATTERY ITSELF SHOWED NO SIGNS OF MALFUNCTION, SWELLING, OR OVERHEATING. THE PCB TEMPERATURE REMAINED WITHIN THE DEVICE'S SPECIFIED OPERATING RANGE (?40°C). ALTHOUGH THE DEVICE FUNCTIONED WITHIN ITS SAFETY PARAMETERS AND NO SERIOUS INJURY OCCURRED, ACTIGRAPH SUBMITTED THE EU MIR AS A REPORTABLE EVENT (REPORT NUMBER (B)(4)) AND IS SUBMITTING THIS FDA 3500 VOLUNTARILY IN AN EFFORT TO REMAIN VIGILANT AND TRANSPARENT. BASED ON EXTENSIVE POST-MARKET SURVEILLANCE DATA COLLECTED SINCE 2012, THERE IS NO INDICATION OF A NEW OR INCREASED RISK ASSOCIATED WITH THIS DEVICE MODEL. NO TRENDS OR RECURRING PATTERNS HAVE BEEN OBSERVED FOR THIS TYPE OF ISSUE. ACTIGRAPH WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS AND TAKE APPROPRIATE ACTION IF ANY NEW RISK SIGNALS EMERGE. 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 BATTERY -- 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.