FORTIUS 420 HYPERBARIC CHAMBER
Received Jul 15, 2025 · Event occurred Jul 9, 2025
Report MW5172645 · MDR key 22506688
Device
Generic name
Chamber, Hyperbaric
Manufacturer
Oxyhealth, Llc.Product problems
- Fire
Patient
NA · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE DECEDENT WAS THE FOUNDER OF THE (B)(6) WHERE THE INCIDENT OCCURRED AND HAD RECENTLY COMPLETED A SAFETY AND CERTIFICATION COURSE PROVIDED BY THE INTERNATIONAL HYPERBARIC ASSOCIATION, INC. (IHA), A NON-PROFIT ORGANIZATION AFFILIATED WITH OXYHEALTH, AND THE INTERNATIONAL BOARD OF UNDERSEA MEDICINE (IBUM). INITIAL REPORT: A MALE CLINIC FOUNDER DIED IN A FLASH FIRE INSIDE AN OXYHEALTH FORTIUS 420 HYPERBARIC CHAMBER DURING SELF-TREATMENT. THE FIRE'S CAUSE IS STILL UNDER INVESTIGATION. THE INDIVIDUAL HAD RECENTLY COMPLETED SAFETY CERTIFICATION TRAINING THROUGH THE INTERNATIONAL HYPERBARIC ASSOCIATION (IHA) AND THE INTERNATIONAL BOARD OF UNDERSEA MEDICINE (IBUM). UPDATE: I AM ATTACHING PHOTOS OF THE HYPERBARIC CHAMBERS THAT WERE IN USE AT THE CLINIC PRIOR TO THE INCIDENT. THESE IMAGES CLEARLY SHOW THE CHAMBERS BEARING BOTH THE COMPANY NAME, OXYHEALTH, AND THE MODEL DESIGNATION, FORTIUS 420. NOTABLY, THE FDA LOGO APPEARS IN TWO LOCATIONS: ON THE EXTERIOR CONTROL PANEL AND ON THE INTERIOR WALL OF THE CHAMBER NEAR THE INTERNAL CONTROLS. THIS USE OF FDA MARKS DOES NOT APPEAR TO BE AUTHORIZED AND MAY CONSTITUTE A VIOLATION OF FEDERAL LAW.