RICHWAY FUJI BIOMAT MINI 7000MX

Description of Event or Problem

SOURCE: (B)(6) / ON (B)(6) 2026, MY BIOMAT MINI 7000MX (SERIAL #: (B)(6)), AN FDA CLASS II MEDICAL DEVICE, SEVERELY OVERHEATED, CAUGHT FIRE, AND ACTIVELY BURNED AT THE POWER CONNECTION PORT WHILE IN USE DURING SLEEP. THE ELECTRICAL FIRE OCCURRED MERE INCHES FROM THE HEAD OF A 73-YEAR-OLD USER, CAUSING HEAVY SMOKE, SEVERE TRAUMA, AND NEARLY RESULTING IN A FATAL CASUALTY. THE PRODUCT LACKS BASIC SAFETY REDUNDANCIES LIKE A THERMAL AUTO-SHUTOFF TO PREVENT ACTIVE COMBUSTION UNDER NORMAL OPERATING CONDITIONS. THE MANUFACTURER, RICHWAY & FUJI BIO INC., IS REFUSING TO ISSUE A FULL REFUND AND IS DEMANDING THE SURRENDER OF THE BURNT PHYSICAL EVIDENCE FOR AN "INTERNAL REVIEW" RATHER THAN ALLOWING AN INDEPENDENT OR FEDERAL INSPECTION. I AM REPORTING THIS SEVERE ADVERSE EVENT AND FIRE HAZARD TO THE FDA AS DIRECTED BY THE CPSC. ADDITIONAL PRODUCT DETAILS: PRODUCT NAME: BIOMAT MINI 7000MX MANUFACTURER: RICHWAY & FUJI BIO INC. SERIAL NUMBER: (B)(6).