Due to the recent influx of complaints the International Hyperbaric Associates is issuing a PRODUCT WARNING for all Oxyhealth portable hyperbaric chambers and calling for an investigation into Oxyhealth’s products and business ethics.
If you have experienced any of the following with your Oxyhealth hyperbaric chamber; slow inflation, rapid inflation, compressor problems, seams separating, windows bulging, zipper failure, etc. with your hyperbaric unit stop use immediately and promptly report the issues to the FDA. Your hyperbaric chamber may be defective and likely for failure causing serious injury or death. Download General Instructions for Filing an FDA Report
Zipper assembly failure and rapid deflation of the Oxyhealth Vitaeris 320 under normal operating pressure. Oxyhealth sent a “zipper repair kit” to their customer to remedy the hyperbaric chamber himself. FDA Report Here
The Oxyhealth Vitaeris 320 hyperbaric chamber exploded during a patient’s treatment. Patient injury reported. FDA Report Here
As the chamber reached full operating pressure the large head-end window exploded. FDA Report Here
An unfortunate event in which Oxyhealth did NOT report to the FDA until more than three years later, only because they were forced to, due to a wrongful death lawsuit – SPARKS v OXYHEALTH LLC. Regardless of fault, the situation needs to reported immediately. This is beneficial for everyone; the manufacturer can implement safety features/warnings to protect the user and the user has clear direction of proper use. Only after the lawsuit against Oxyhealth, LLC did they included the warning, “ATTENDANT REQUIRED AT ALL TIMES” label. Yet Oxyhealth sales reps still promote “self-treatment”. FDA Report Here
Patient was self treating in an Oxyhealth Vitaeris 320 hyperbaric chamber and had a very difficult time opening the pressure release valve. After exerting nearly all their strength to exit the chamber they noticed that the threads from the chamber cover had come loose and wrapped around the vale stem. This made it nearly impossible to open. FDA Report Here
Furthermore, a few recent bursting reports of the Oxyhealth Quamvis 320 have been received as well. Many of these Quamvis 320 units are operating at unsafe pressures, well beyond the FDA maximum allowed pressure for a portable hyperbaric chamber. If you are utilizing a Quamvis 320 hyperbaric chamber, especially beyond pressures of 1.3 ATA (4 PSI), you are advised to STOP USE IMMEDIATELY and contact your portable hyperbaric chamber sales representative for further information. Report any issues regarding your hyperbaric chamber to the FDA immediately.