MAUDE Adverse Event Report: OXYHEALTH, LLC VITAERIS 320 HYPERBARIC OXYGEN CHAMBER; CHAMBER, HYPERBARIC

Health Effect - Clinical Codes	Headache (1880); Lethargy (2560); Blood Bicarbonate Increased (4826)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called in regarding a hyperbaric oxygen chamber that she decided to try out somewhere.For 3 months she could get unlimited 1.5hr sessions daily.Patient felt headaches and lethargic each time after getting out of the chamber.Patient co2 levels were 3,444 after leaving the chamber.The next day the patient went and measured her levels again and it was 2,444.Patient reached out to the manufacturer and was offered part of her money back.Patient has a concern that the co2 levels isn't being monitored properly.

• Brand Name: VITAERIS 320 HYPERBARIC OXYGEN CHAMBER
• Common Device Name: CHAMBER, HYPERBARIC
• Manufacturer (Section D): OXYHEALTH, LLC
• MDR Report Key: 24666182
• Report Number: MW5185604
• Device Sequence Number: 14453875
• Product Code: CBF
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2026
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: White