Description of Event or Problem · 0
THE REPORTER IS A HEALTHCARE TECHNOLOGY DEVELOPER (AKN) UTILIZING THE SAMSUNG GALAXY WATCH PLATFORM, WHICH IS CLEARED AS A CLASS II MEDICAL DEVICE UNDER FDA 510(K) CLEARANCE K240909 (FOR THE ECG APP AND IRREGULAR HEART RHYTHM NOTIFICATION- IHRN). FOLLOWING A MANDATORY, MANUFACTURER-PUSHED FIRMWARE UPDATE (ONE UI (USER INTERFACE) 8 / WEAR OS (OPERATING SYSTEM) 5), THE DEVICE'S PHYSIOLOGICAL SENSOR ARRAY, PHOTOPLETHYSMOGRAPHY (PPG) SENSORS, HEART RATE TRACKING, ECG, AND WRIST-DETECTION ALGORITHMS FAILED COMPLETELY. THE DEVICE IS NOW UNABLE TO COLLECT, PROCESS, OR TRANSMIT CARDIAC TELEMETRY OR CARDIAC EVENT NOTIFICATIONS, PERFORM ECG CORRECTION, OR PROVIDE IRREGULAR HEART RHYTHM MONITORING. STANDARD DIAGNOSTIC FUNCTIONS ARE COMPLETELY DISABLED, RENDERING THE CLEARED MEDICAL DEVICE FUNCTION ENTIRELY NON-OPERATIONAL. DESPITE PROMPT REPORTING, THE US SPONSOR, (B)(6) (SAMSUNG ELECTRONICS AMERICA), AND THEIR EXECUTIVE ESCALATION TEAM HAVE OFFICIALLY REFUSED TO INVESTIGATE OR REMEDIATE THIS SOFTWARE-INDUCED HARDWARE REGRESSION. INSTEAD, THE MANUFACTURER HAS CLASSIFIED THIS FIRMWARE-INDUCED DEFECT AS A RETAIL "OUT-OF-WARRANTY HARDWARE ISSUE" AND DEMANDED THAT THE DEVELOPER PAY AN OUT OF-POCKET SERVICE FEE TO REPAIR A DEFECT INITIATED BY SAMSUNG'S OWN SOFTWARE DEPLOYMENT. THIS FAILURE TO REMEDIATE A SOFTWARE-INDUCED DEGRADATION OF CLEARED MEDICAL TELEMETRY CONSTITUTES A NON-CONFORMANCE UNDER 21 CFR(CODE OF FEDERAL REGULATIONS) PART 820 QUALITY SYSTEM REGULATIONS (QMSR(QUALITY MANAGEMENT SYSTEM REGULATION)) REGARDING CORRECTIVE ACTION (CAPA(CORRECTIVE AND PREVENTIVE ACTION)) AND COMPLAINT HANDLING. CONSISTENT FAILURE OF THE ECG APPLICATION AND SAMSUNG HEALTH MONITOR APPLICATION TO INITIALIZE OR READ HEART RATE DATA POST-UPDATE. VISUAL INSPECTION CONFIRMS THAT THE PHOTOPLETHYSMOGRAPHY (PPG) GREEN/RED SENSOR LEDS DO NOT ACTIVATE UPON SKIN CONTACT, DIAGNOSTIC BATTERY STATUS REPORTS INACCURATE STATE OF CHARGE (BRICKED BATTERY CONTROLLER SHOWING FALSE RAPID DISCHARGE).