PERRY SIGMA II
Received May 1, 2012 · Event occurred Apr 12, 2012
Report MW5025262 · MDR key 2561447
Device
Generic name
Hyperbaric Oxygen Chamber
Manufacturer
Perry BaromedicalProduct problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
DURING THE ASCENT OF OUR LAST HYPERBARIC O2 TREATMENT, IT WAS NOTED THAT THE CHAMBER WAS ASCENDING SLOWER THAN NORMAL. THE DIVE WAS COMPLETED WITH NO ILL EFFECTS TO THE PT. AFTER THE DIVE WAS COMPLETED, THE CHAMBER MFR (PERRY BAROMEDICAL) WAS CALLED AND TOLD OF THE PROBLEM. THEIR TECH, (B)(4) CALLED US BACK AND INSTRUCTED US ON HOW TO ADJUST THE NEEDLE VALVE CONTROL KNOT TO INCREASE THE RATE OF ASCENT OF THE CHAMBER. THE RATE ADJUSTMENT WAS TESTED DURING 5 MORE TIMED DIVES OF THE CHAMBER. THE NEXT MORNING ((B)(6) 2012) THE CHAMBER WAS TESTED AGAIN WITH COMPRESSION AND DECOMPRESSION RATES FALLING WITHIN THE MFRS SPEC'S. (B)(4) (PERRY'S TECH) WAS ON THE PHONE DURING THE TESTING AND APPROVED THE USE OF THE CHAMBER. (B)(6), WAS INFORMED OF THE SITUATION WITH THE CHAMBER. (B)(4).