FDA Adverse Event Death Summary report: N

OXYHEALTH FORTIUS 420 HYPERBARIC OXYGEN CHAMBER

MDR report key: 22796994 · Received August 13, 2025

Report

Report Number
MW5174457
Event Type
Death
Date Received
August 13, 2025
Date of Event
July 9, 2025
Report Date
August 10, 2025
Manufacturer
OXYHEALTH LLC.
Product Code
CBF
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
AZ, US
Reporter Occupation
501
Health Professional
N

Narratives

Description of Event or Problem · 0

(B)(6) WAS FOUND DECEASED INSIDE OF A HYPERBARIC OXYGEN CHAMBER AT HIS HEALTH CLINIC, (B)(6), ON THE LATE EVENING OF (B)(6) 2025. (B)(6) WIFE HAD NOT HEARD FROM HIM, AND AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO CONTACT HIM BY PHONE, WENT TO THE HEALTH CLINIC. UPON ARRIVAL, SHE FOUND THE FACILITY FILLED WITH SMOKE. EMERGENCY RESPONDERS WERE SUBSEQUENTLY NOTIFIED, AND ARRIVED AT THE HEALTH CLINIC AT APPROXIMATELY 10:50 P.M. MST(MOUNTAIN STANDARD TIME). EMERGENCY RESPONDERS DETERMINED THAT A FLASH FIRE OCCURRED WHILE (B)(6) HAD BEEN UNDERGOING SELF-TREATMENT INSIDE THE SEALED CHAMBER, AT A PRESSURE OF 2.2 ATA(ATMOSPHERE ABSOLUTE ). REMNANTS OF SEVERAL ELECTRONIC DEVICES WERE FOUND WITHIN THE CHAMBER, INCLUDING A HANDHELD COMMUNICATIONS DEVICE, HEADSET, EARPHONES, BRAIN-TAP, BATTERY POWER BANKS, CELL PHONE, ELECTRONIC TABLET, CHARGING CABLES, FAN AND POSSIBLY A RED LIGHT THERAPY DEVICE. BULKY BLACKENED MASSES WERE PRESENT WITH SIGNS OF SWELLING AND CRACKING, WHICH ARE SUSPECTED TO BE THE LITHIUM ION BATTERY PACKS POWERING MULTIPLE OF THOSE ITEMS. IT IS SUSPECTED THAT THE LITHIUM ION BATTERIES WERE A SOURCE OF IGNITION THAT CAUSED A FLASH FIRE WITHIN THE SEALED CHAMBER. FURTHER INSPECTION OF THE INCIDENT'S PHOTOGRAPHS REVEALED THAT THE CHAMBER MAINTAINED ITS INTEGRITY, WHILE CONTAINING THE FIRE EVENT. THE CHAMBER WAS A FORTIUS 420, SERIAL NO. (B)(6), MANUFACTURED BY PROFESSIONAL PIPING SYSTEMS, LLC, 406 E. PIONEER STREET, PHOENIX, ARIZONA 85040 FOR (B)(4). THE CHAMBER RECEIVED ITS FINAL INSPECTION ON JANUARY 19, 2024. THE 510K PREMARKET APPROVAL APPLICATION FOR THE CHAMBER WAS APPROVED ON NOVEMBER 15, 2004. (B)(6) LEARNED ABOUT THE INCIDENT FROM (B)(6). MS. (B)(6) THE INTERNATIONAL HYPERBARIC ASSOCIATION. THE (B)(6) THEREAFTER DISCUSSED THE INCIDENT WITH (B)(6), MAS, MS, CHT, SAFETY DIRECTOR AT (B)(6) AND RESEARCH PHYSIOLOGIST FOR THE HYPERBARIC INSTITUTE FOR RESEARCH AND TRAINING, AND POLICE DETECTIVES/FIRE MARSHALS. (B)(6) IS UNDER THE IMPRESSION THAT THE CHAMBER IS STILL AT THE FACILITY. MR. (B)(6) WERE NOT GRANTED ACCESS TO VIEW THE DEVICE. PROFESSIONAL PIPING SYSTEMS, LLC.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
76213 OXYHEALTH FORTIUS 420 HYPERBARIC OXYGEN CHAMBER CHAMBER, HYPERBARIC CBF OXYHEALTH LLC. FORTIUS 420

Patients

Seq Age Sex Outcome Treatment
1 43 YR Male Death