inforMED
MalfunctionCBF

VITAERIS 320 PACKAGE

Received Jul 13, 2018 · Event occurred Jul 9, 2018

Report MW5078391 · MDR key 7689303

Device

Generic name

Hyperbaric Chamber

Manufacturer

Oxyhealth, Llc

Model number

V320

Catalog number

VITAERIS

Product problems

  • Gas Output Problem
  • Mechanical Problem
  • Noise, Audible

Patient

66 YR

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

Narrative

Description of Event or Problem

USED AN OXYHEALTH VITAERIS 320. THE OXYGEN CONCENTRATOR PACKAGE THEY SOLD DIRECTLY TO ME STOPPED WORKING AND STARTED RUMBLING LOUDLY AND COULDN'T BREATHE WHILE IN THE UNIT, THE MASK WAS NOT SUPPLYING OXYGEN. I CALLED THEM TO COMPLAIN AND THEY CLAIMED THEY DON'T SELL IT, BUT I HAVE AN INVOICE OF THE PRODUCT AND SPENT THE MONEY, OXYHEALTH SAID THEY WOULD GIVE ME A DEAL AND CHARGE (B)(6). HOWEVER, WHEN I CALLED THEY SAID THEY DON'T SELL IT AND WON'T FIX THE CONCENTRATOR.