FDA Adverse Event Death Summary report: N

FORTIUS 420 HYPERBARIC CHAMBER

MDR report key: 22506688 · Received July 15, 2025

Report

Report Number
MW5172645
Event Type
Death
Date Received
July 15, 2025
Date of Event
July 9, 2025
Report Date
July 13, 2025
Manufacturer
OXYHEALTH, LLC.
Product Code
CBF
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER
Health Professional
*

Narratives

Description of Event or Problem · 0

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1572350 FORTIUS 420 HYPERBARIC CHAMBER CHAMBER, HYPERBARIC CBF OXYHEALTH, LLC.

Patients

Seq Age Sex Outcome Treatment
1 NA Male Death