Description of Event or Problem · 0
DEAR FDA, I AM WRITING TO REPORT A SERIOUS SAFETY INCIDENT INVOLVING THE FOTOSY WRIST BLOOD PRESSURE MONITOR (AMAZON ASIN B0DPLYX26V), WHICH CONTAINS A BUILT-IN LITHIUM BATTERY AND IS CURRENTLY BEING SOLD IN THE UNITED STATES. IN EARLY (B)(6) 2025, WHILE I WAS USING THE DEVICE FOR A ROUTINE BLOOD PRESSURE MEASUREMENT, IT SUDDENLY BEGAN TO HEAT UP FROM THE BOTTOM AREA. THE TEMPERATURE INCREASED RAPIDLY AND BECAME EXTREMELY HOT ON MY WRIST. I NOTICED THE PLASTIC CASING ON ONE SIDE STARTING TO BULGE AND SOFTEN, AND A STRONG BURNT CHEMICAL ODOR APPEARED AT THE SAME TIME. I IMMEDIATELY REMOVED THE DEVICE FROM MY WRIST, AND SHORTLY AFTERWARD THE UNIT PRODUCED A DISTINCT POPPING SOUND, STRONGLY SUGGESTING AN INTERNAL BATTERY FAILURE. THE HEAT LEVEL HAD ALREADY REACHED A POINT WHERE IT COULD HAVE CAUSED BURNS OR IGNITED NEARBY OBJECTS. I WAS FORTUNATE TO REACT QUICKLY, BUT THE DEVICE CAME VERY CLOSE TO CAUSING A FIRE. BASED ON MY EXPERIENCE, THE DEVICE MAY HAVE A CRITICAL LITHIUM-BATTERY OR INTERNAL ELECTRICAL DEFECT. THE BEHAVIOR I OBSERVED INDICATES A POTENTIAL THERMAL RUNAWAY, SHORT CIRCUIT, OR FAILURE OF THE BATTERY PROTECTION SYSTEM. BECAUSE THIS IS A WEARABLE DEVICE IN DIRECT CONTACT WITH THE SKIN, THE OVERHEATING POSES A SIGNIFICANT RISK OF INJURY, AND SIMILAR INCIDENTS COULD RESULT IN BURNS, PROPERTY DAMAGE, OR FIRE. THIS ISSUE OCCURRED DURING NORMAL USE--NOT DURING CHARGING--WHICH MAKES THE HAZARD EVEN MORE CONCERNING. GIVEN THAT THE PRODUCT IS USED FREQUENTLY BY ELDERLY INDIVIDUALS OR PEOPLE WITH MEDICAL CONDITIONS, I BELIEVE THIS SITUATION REQUIRES IMMEDIATE ATTENTION. FOR THE SAFETY OF ALL CUSTOMERS, I RESPECTFULLY REQUEST THAT THIS ASIN BE TEMPORARILY SUSPENDED FROM SALE UNTIL AMAZON COMPLETES A FULL SAFETY INVESTIGATION. ALLOWING THE LISTING TO REMAIN ACTIVE DURING AN UNRESOLVED BATTERY-RELATED HAZARD MAY PUT OTHER USERS AT SERIOUS RISK. THANK YOU FOR YOUR PROMPT ATTENTION TO THIS MATTER. SINCERELY, (B)(6).