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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OXYHEALTH, LLC. FORTIUS 420 HYPERBARIC CHAMBER; CHAMBER, HYPERBARIC
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OXYHEALTH, LLC. FORTIUS 420 HYPERBARIC CHAMBER; CHAMBER, HYPERBARIC Back to Search Results
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 07/09/2025
Type of Reportable Event Death
Event or Problem Description
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.
 
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Brand Name
FORTIUS 420 HYPERBARIC CHAMBER
Common Device Name
CHAMBER, HYPERBARIC
Manufacturer (Section D)
OXYHEALTH, LLC.
MDR Report Key22506688
Report NumberMW5172645
Device Sequence Number13087165
Product Code CBF
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/13/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/15/2025
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
Patient SexMale
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