HYPERBARIC OXYGEN THERAPY (HBOT) CHAMBER

Description of Event or Problem

ON (B)(6) 2025, MY WIFE, (B)(6), WAS PLACED IN A HYPERBARIC OXYGEN THERAPY (HBOT) CHAMBER (B)(6). DURING THE SESSION, THE FOLLOWING OCCURRED: 1. THE TECHNICIAN ON DUTY, WHO IDENTIFIED HERSELF (B)(6), SEALED (B)(6) INSIDE THE CHAMBER BUT FAILED TO ACTIVATE THE OXYGEN SYSTEM. NO OXYGEN FLOWED INTO THE CHAMBER DURING THE SESSION. 2. THE TECHNICIAN'S WALKIE-TALKIE WAS NONFUNCTIONAL, AND THE FACILITY HAD NO VIDEO OR AUDIO MONITORING SYSTEM IN PLACE. 3. NO LICENSED MEDICAL PROFESSIONAL OR SUPERVISING CHIROPRACTOR WAS ON SITE. THE TECHNICIAN APPEARED UNFAMILIAR WITH THE EQUIPMENT AND UNABLE TO OPERATE BASIC CONTROLS. 4. (B)(6) REALIZED SOMETHING WAS WRONG AND BEGAN BANGING ON THE CHAMBER GLASS TO SIGNAL DISTRESS. SHE WAS DISCOVERED ONLY BY COINCIDENCE WHEN THE TECHNICIAN HAPPENED TO WALK PAST. 5. THE ABSENCE OF OXYGEN FLOW PLACED (B)(6) AT RISK OF HYPOXIA AND ASPHYXIATION. HAD SHE NOT BEEN NOTICED, SERIOUS INJURY OR DEATH COULD HAVE OCCURRED. THE CHAMBER MAY OR MAY NOT HAVE BEEN PRESSURIZED AT THE TIME, BUT REGARDLESS, THE FAILURE TO SUPPLY OXYGEN, ABSENCE OF FUNCTIONAL COMMUNICATION SYSTEMS, AND LACK OF LICENSED SUPERVISION REPRESENT CRITICAL SAFETY FAILURES IN THE USE OF THIS MEDICAL DEVICE. THIS FACILITY ALSO ADVERTISES HBOT TREATMENT FOR CHILDREN, MAGNIFYING THE PUBLIC HEALTH RISK. I REQUEST THAT FDA REVIEW THIS INCIDENT AS A POTENTIAL CASE OF UNSAFE DEVICE OPERATION, LACK OF ADHERENCE TO DEVICE LABELING/SAFETY REQUIREMENTS, AND SYSTEMIC MISUSE.