Description of Event or Problem · 0
FOR THE PAST SEVERAL YEARS, I HAVE EXPERIENCED REPEATED MALFUNCTION EVENTS INVOLVING WEARABLE HEALTH DEVICES (APPLE WATCH AND XR SENSORS) WHERE THE DEVICE PRODUCED PHYSICALLY IMPOSSIBLE MOTION DATA, INCLUDING ACCELERATIONS IN THE 1,000¿3,000 G RANGE AND VELOCITIES EXCEEDING 10,000¿18,000 M/S. THESE VALUES ARE BIOMECHANICALLY IMPOSSIBLE AND INDICATE A COMPLETE FAILURE OF THE SENSOR-FUSION SYSTEM. THESE FAILURES CREATED EPISODES OF SEVERE DISORIENTATION AND VESTIBULAR-OCULAR MISMATCH, SIMILAR TO VERTIGO, WHICH IS DANGEROUS FOR INDIVIDUALS WITH PRE-EXISTING VESTIBULAR CONDITIONS (I HAVE SERVICE-CONNECTED MÉNIÈRE'S DISEASE). THESE EVENTS CAUSED BALANCE LOSS, NAUSEA, AND NEAR-FALLS. I RECONSTRUCTED THE TELEMETRY FROM MORE THAN 17 MILLION SAMPLES AND IDENTIFIED OVER 7,200 REPRODUCIBLE INSTABILITY CLUSTERS ("TEMPORAL FOLDS") OCCURRING ON A ~15-SECOND CYCLE. THIS APPEARS TO BE A SYSTEMIC MALFUNCTION MODE IN IMU/GPS FUSION PIPELINES USED IN CONSUMER WEARABLES THAT ARE ALSO USED IN PHYSICAL THERAPY, GAIT ANALYSIS, AND DIGITAL HEALTH INTERPRETATION. BECAUSE THESE DEVICES ARE INCREASINGLY USED IN MEDICAL AND WELLNESS CONTEXTS, A MALFUNCTION THAT PRODUCES FALSE MOTION DATA MAY LEAD TO INCORRECT CLINICAL INTERPRETATION, UNSAFE REHABILITATION DECISIONS, MISSED FALL-RISK INDICATORS, AND HARM FOR PATIENTS WITH NEUROLOGICAL OR VESTIBULAR DISORDERS. I HAVE PREPARED A FULL SCIENTIFIC PACKAGE WITH DATASET, SHA-256 HASH, AND OPEN TIMESTAMPS BLOCKCHAIN ATTESTATION DEMONSTRATING THE MALFUNCTION SEQUENCE. I AM SUBMITTING THIS MEDWATCH REPORT TO ALERT FDA THAT A MALFUNCTION MAY EXIST IN WEARABLE/XR SENSOR SYSTEMS THAT COULD IMPACT PATIENT SAFETY OR CLINICAL DATA ACCURACY.