inforMED
MalfunctionCBF

VITAERIS320 PORTABLE HYPERBARIC OXYGEN CHAMBER

Received Jan 11, 2018 · Event occurred Jan 7, 2018

Report MW5074543 · MDR key 7186485

Device

Generic name

Portable Hyperbaric Oxygen Chamber

Manufacturer

Oxy Health

Model number

VITAERIS 320

Product problems

  • Mechanics Altered

Patient

64 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

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.