Vitaeris 320 15C37179Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10856039006011), received between Jan 11, 2018 and Jan 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2018Mechanics Altered

  THIS INVOLVES THE OXYHEALTH VITAERIS320 PORTABLE HYPERBARIC OXYGEN CHAMBER. THERE WAS NO PROBLEM WITH THE CHAMBER'S FUNCTIONALITY BUT A DESIGN FLAW WITH THE COVER CAUSED WHAT COULD HAVE BEEN A DANGEROUS SITUATION, AT THE END OF A PERIOD OF SELF-TREATING I ATTEMPTED TO EMERGE FROM THE CHAMBER BUT COULD NOT TURN THE PRESSURE RELEASE VALVE. ULTIMATELY I HAD TO EXERT NEARLY MY FULL STRENGTH TO OPEN THE VALVE WHILE LYING ON MY BACK. AFTER EXITING I DISCOVERED THAT SEVERAL THREADS WHERE THE COVER HAD BEEN SEWN TOGETHER HAD COME LOOSE AND CONTACTED THE VALVE STEM. WHEN I CLOSED THE VALVE FROM INSIDE THE CHAMBER, THE THREADS FROM THE COVER WRAPPED AROUND THE VALVE STEM WHICH, AS I CLOSED IT CREATED A TIGHT A SEAL AROUND THE STEM WHICH MADE IT ALMOST IMPOSSIBLE TO RELEASE THE VALVE. A PERSON OF LESSER STRENGTH THAN I, A SMALL WOMAN FOR EXAMPLE, WOULD POSSIBLY HAVE NOT BEEN ABLE TO EXIT THE CHAMBER UNTIL SOMEONE FROM OUTSIDE THE CHAMBER WORKED THE VALVE LOOSE. THIS IS A DANGER FOR A PERSON WHO CHOOSES TO SELF TREAT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7186485 ↗