Recent FDA reports have shed new light on the tragic hyperbaric chamber fatality that occurred on July 9, 2025, in Lake Havasu City, Arizona. The incident involved a fatal flash fire inside a Fortius 420 hyperbaric chamber manufactured by Oxyhealth. New details from two FDA MAUDE reports1 confirm the incident and raise serious concerns over improper device use, environmental hazards, and disregard for established safety protocols.
Probable Cause Points to Oxygen Leak and Electronics
According to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, the Fortius 420 hyperbaric chamber was in operation at the time of the incident and was completely destroyed by fire. Investigators reported that several items were recovered from within the chamber, including a melted electronic tablet, a cell phone, and a fan—clear indications that battery-powered electronics were present and in use during treatment.
While the exact ignition source remains under investigation, the evidence suggests that supplemental oxygen delivery systems, combined with these electronic devices, may have contributed to ignition within the oxygen-enriched, pressurized environment. In such conditions, elevated oxygen levels drastically increase the flammability of materials, and even a minor electrical spark can escalate into a flash fire. This combination of oxygen leakage and an ignition source remains the leading theory behind the fatal event.
Disregard for Safety Warnings and Evidence of Noncompliance
Despite long-established fire-safety guidance, many clinics and promotional materials continue to depict unsafe practices. Oxyhealth sales videos2 and marketing images have shown patients and staff using electronic devices inside the Fortius 420 chamber. Such imagery normalizes high-risk behavior and undermines the strict prohibitions that should be enforced in oxygen-enriched environments.
Additionally, several clinics have been documented operating Fortius 420 chambers equipped with dual oxygen connectors inside the vessel. This configuration strongly suggests use for double-occupancy treatments—directly contradicting the chamber’s FDA 510(k) clearance (K041007) as a monoplace device intended for single-patient use. Such unauthorized configurations violate the chamber’s cleared purpose and increase the risk of dangerous oxygen buildup.
The Role of Oxyhealth and the International Hyperbarics Association
Both Oxyhealth and affiliated organizations such as the International Hyperbarics Association (IHA) have maintained a public image of safety leadership within the HBOT industry. However, their ongoing promotion of the Fortius 420 without adequate enforcement of safety and usage guidelines raises serious questions about their commitment to clinical safety.
Following the July 2025 incident, the IHA released a statement3 addressing the tragedy, but the message appears to represent a shift in tone rather than a full acknowledgment of responsibility. Historically, IHA materials and affiliated training programs portrayed the use of electronic devices inside hyperbaric chambers as acceptable, especially within “flow-through” oxygen systems promoted by Oxyhealth. Their more recent statement, advising against the use of electronics, effectively reverses their prior position while avoiding acknowledgment that earlier guidance may have contributed to unsafe practices.
By continuing to market the Fortius 420 using imagery and demonstrations that blatantly contradict widely accepted fire safety protocols and FDA-cleared usage, Oxyhealth and its affiliates have contributed to a culture that may underestimate the risks associated with hyperbaric therapy. Former Oxyhealth president Samir Patel—now deceased—regularly downplayed those risks in public-facing materials. In one video from the IHA’s HBOT Workshop, Patel is seen igniting firecrackers and operating a gas burner inside a pressurized portable chamber in an attempt to demonstrate the chamber’s “safety,” and after exiting, jokes, “Tada, I’m not dead!”
In another video, Patel is seen igniting fireworks indoors of the Oxyhealth warehouse where hyperbaric chambers are visibly present—an act that visibly undermines the serious fire risks associated with hyperbaric chambers and oxygen-enriched environments. While likely intended to be provocative or humorous, such demonstrations trivialize critical safety standards and may have contributed to a broader perception that Oxyhealth chambers are inherently safe regardless of conditions. This normalization of risk, reinforced through public displays and promotional materials, may help explain the unsafe practices now observed in some clinical settings.
Fire safety in hyperbaric medicine is not a topic for mockery or demonstration stunts; it is a matter of life and death. The casual dismissal of these risks by those once leading the industry has fostered a culture of complacency that endangers both patients and practitioners. True leadership demands accountability, respect for science, and an unwavering commitment to safety—qualities that must now replace spectacle if tragedies like this are to be prevented again.
A Warning to Patients and Practitioners
Patients seeking hyperbaric oxygen therapy should carefully verify that their chosen facility is accredited and compliant with current safety standards. Treatments should only be performed at centers that prohibit the use of electronics inside chambers, follow approved oxygen handling protocols, and operate strictly within the device’s FDA-cleared indications.
This tragic event is a sobering reminder that even minor deviations from safety standards in pressurized, oxygen-rich environments can lead to catastrophic consequences. Until the industry enforces stronger oversight and accountability, patients are urged to seek care only from accredited, safety-compliant hyperbaric facilities.
Sources:
- FDA MAUDE Reports
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=22796994&pc=CBF
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=22506688&pc=CBF ↩︎ - Oxyhealth Fortius 420 Promotion Video
https://youtu.be/hJB_z6Zi1Yc?si=VlnEgRlGU7PYMBJq&t=77 ↩︎ - International Hyperbarics Association – Havasu Hyperbaric Chamber Incident
https://www.ihausa.org/havasu-hyperbaric-chamber-incident ↩︎
⚠️ Choose an Accredited Hyperbaric Therapy Provider for Your Safety ⚠️
Prospective and current hyperbaric patients must exercise due diligence. Use the links below to find accredited facilities that follow strict safety protocols—and report any that do not.
✅ Search for accredited hyperbaric facilities
✅ Download current list of accredited hyperbaric facilities
✅ Report hyperbaric-related incidents and accidents
