inforMED
InjuryCBF

HYPERBARIC OXYGEN CHAMBER

Received Dec 13, 2007 · Event occurred Jan 10, 2006

Report MW5004688 · MDR key 966148

Device

Generic name

Hyperbaric Oxygen Chamber

Manufacturer

Accelecare

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Unknown (for use when the device problem is not known)

Patient

57 YR

  • Blurred Vision
  • Loss of Vision
  • Loss of consciousness
  • Therapy/non-surgical treatment, additional
  • Hospitalization required

Narrative

Description of Event or Problem

TO WHOM THIS MAY CONCERN: CAN SOMEONE OUT THERE HELP US??? MALE IS A DIABETIC. BACK IN 2005, HE UNDERWENT SURGERY FOR TWO TOES AMPUTATED ON HIS LEFT FOOT IN CARBONDALE. WE WERE TOLD ABOUT THE HYPERBARIC TREATMENTS. WE CHECKED INTO IT, DISCUSSED IT WITH THE PHYSICIAN THERE AT HOSPITAL. THEY CHECKED HIM OUT -EXAMINED HIM- HEAD TO TOE AND STATED THAT HE WAS A VERY GOOD CANDIDATE FOR THEIR PROGRAM, AND WAS TOLD THAT EVERYTHING WAS FINE. WE STARTED THE TREATMENTS TWO MONTHS LATER. WE CHOSE TO GO INTO HYPERBARIC CHAMBER. THESE CHAMBER VISITS WERE 5 DAYS A WEEK FOR 2 MONTHS. NOTE THIS: HYPERBARIC MEDICINE IS CONSIDERED EXTREMELY SAFE UNDER APPROPRIATE SUPERVISION AND UTILITY. TOXIC EFFECTS OF OXYGEN ARE OBSERVED AT EXTREMELY HIGH DOSES OVER PROLONGED PERIODS. SUSCEPTIBLE PTS NEED TO BE RECOGNIZED AND MODIFICATIONS MADE TO PREVENT THE MANIFESTATIONS OF OXYGEN TOXICITY. DAMAGING OR TOXIC EFFECTS OF OXYGEN THERAPY. IN 2006, HE WENT TO THE ER AT HOSPITAL DUE TO A FAINTING SPELL. THEY COULD NOT FIND ANYTHING WRONG WITH HIM, NOT EVEN AN EYE PROBLEM. SINCE THEY COULD NOT FIND ANYTHING, THEY DECIDED TO DO THE EEG SCAN ON HIM THINKING THAT IT WOULD MAYBE SHOW SOMETHING GOING ON IN THE BRAIN THAT THE OTHER TEST WOULD NOT SHOW. BECAUSE IT SHOWED NOTHING OF SIGNIFICANCE, THEY DECIDED TO DO A TAKE HOME-OVER THE WEEKEND EEG CAP WHICH HE WORE THE WHOLE WEEKEND TO MONITOR WHATEVER THEY WERE LOOKING AT IT TO MONITOR. THE CAP WAS REMOVED THAT MONDAY MORNING. THE STAFF STATED THAT THEY DIDN'T WANT ANY COMPLICATIONS FROM THE EEG TEST CONNECTING WITH THE CHAMBER; THEREFORE, THEY THOUGHT THAT IF HE WAITED ABOUT AN HOUR BEFORE GOING BACK INTO THE HYPERBARIC CHAMBER EVERYTHING SHOULD BE OK. HE WENT BACK INTO THE CHAMBER ABOUT AN HOUR AFTER THE EEG CAP REMOVAL TEST. RIGHT AFTER THE REMOVAL OF THE CAP AND GOING BACK INTO THE HYPERBARIC CHAMBER HE BEGAN TO EXPERIENCE VISION PROBLEMS. HE HAD NOT HAD THIS EXPERIENCE BEFORE. THINGS BEGAN TO GO DARK ON HIM. WE WERE TOLD THAT THE HYPERBARIC CHAMBER TREATMENTS MAY CAUSE BLURRED VISION WHICH THAT'S THE ONLY COMPLICATION THAT THEY HAVE EXPERIENCED, BUT NOT DARKNESS. HE WAS TOLD THAT THIS WAS NORMAL, THAT MANY PEOPLE EXPERIENCE BLURRED VISION AND THAT IT WOULD GO AWAY AND THAT HE SHOULD CONTINUE THE TREATMENTS. AFTER A PERIOD OF TIME WE REALLY BEGAN TO QUESTION THEM ABOUT WHAT WAS GOING ON WITH HIS EYES. IT WAS BRUSHED OFF AGAIN AS DON'T WORRY ABOUT IT. IT WAS STATED THAT IT WOULD PASS AFTER ABOUT 6-8 WEEKS AFTER THE LAST TREATMENT. IT BEGAN TO REALLY BOTHER HIM BECAUSE THIS WAS BEYOND BLURRED VISION. WE SHARED THIS AGAIN WITH DOCTOR, BUT HE INSISTED THAT WE CONTINUE THE TREATMENTS UNTIL COMPLETION. HIM REQUESTED NOT TO GO BACK INTO THE CHAMBER BECAUSE HIS VISION WAS GETTING WORSE EACH TIME HE WENT IN. FINALLY WE ASKED AGAIN ABOUT WHAT WAS GOING ON. AT THAT POINT, THEY STATED THAT THEY DID NOT KNOW, THAT THIS HAS NOT HAPPENED BEFORE. WE STOPPED THE TREATMENTS ON OUR OWN. PROBLEM WAS, WHEN WE STOPPED THE CHAMBER TREATMENTS IT WAS TOO LATE. DR PERRY STATED THAT THIS WAS RARE/ A FIRST FOR THEM. WE CALLED ANOTHER FACILITY TO SEE IF THIS WAS THE WAY HYPERBARIC WORKED. THEY STATED THAT WHEN HIS VISION GOT TO THE POINT OF DARKNESS THE TREATMENTS SHOULD HAVE STOPPED. WE ASKED TO BE REFERRED TO AN EYE DOCTOR. AGAINST THE WISHES OF DOCTOR WE WENT TO AN EYE DOCTOR WHO WAS VERY BAFFLED AS TO WHAT WAS GOING ON. HE STATED IN ALL HIS MEDICAL WORK, HE HAD NEVER SEEN THIS HAPPEN TO THE EYES. USUALLY SOMETHING LIKE DIABETIC RETINOPATHY WOULD BE THE RESULTS, BUT HE STATED THAT THIS WAS NOT THE WORK OF THE NON-PROLIFIC RETINOPATHY. I'VE TAKEN MY HUSBAND TO SEVERAL DOCTORS THROUGHOUT THE STATES. EACH OF THEM STATED THAT THIS IS A RARE CASE THAT THEY COULDN'T FIGURE IT OUT. HE HAS SEEN 1 NEUROLOGIST AND 5 EYE SPECIALISTS. EACH OF THEM ARE BAFFLED. THIS IS NOT THE NORM THEY SAY. THEY STATE THAT THEY KNOW VERY LITTLE ABOUT HYPERBARIC THERAPY, SO THEY REALLY DON'T KNOW HOW THE EFFECTS HINDERS THE EYE PROCESS ACCEPT POSSIBLY TOO MUCH TIME IN THE CHAMBER, OR TOO MANY TIMES. THEY STATE THAT IN ALL PURPOSE, THIS SHOULD NOT BE HAPPENING TO HIM. EVERYTHING SEEMS TO BE NORMAL ON HIS TEST. OH BY THE WAY DR PERRY- THE HYPERBARIC DOCTOR-LEFT THE FACILITY RIGHT AFTERWARDS TO GO WORK WITH A CONSTRUCTION COMPANY. THERE IS ALWAYS A FIRST TIME IN ANYTHING DONE. VIOXX, MRI, MEDICAL MALPRACTICE, YOU NAME IT. THERE COULD BE SOMEONE ELSE OUT THERE RIGHT NOW WHO HAS HAD A SIMILAR EXPERIENCE, BUT BECAUSE THEY COULDN'T GET IT ON THE BOOKS, OR NO ONE HAS EVER READ OR HEARD OF THEIR RARE CASES IT IS BRUSHED UNDER THE RUG, IT IS NEVER PUBLICIZED. UNDERSTAND THIS, IF THIS CASE DOESN'T GO ANYWHERE, HOW WILL ANYONE ELSE KNOW IF THERE HAS EVER BEEN A CASE REPORTED OF EXPERIENCED BLINDNESS AFTER EEG/HYPERBARIC CONNECTIONS? MANY TIMES THINGS ARE NOT PUBLICIZED BECAUSE THEY DON'T WANT TO HURT THEIR PRODUCT. IT IS NOT FAIR TO PEOPLE WHEN THEY EXPERIENCE INCIDENTS THROUGH A MEDICAL MISHAP AND ARE TOLD, OUR BRAIN CAN'T COMPREHEND WHAT HAPPENED TO YOU, OR IT'S NEVER BEEN REPORTED, THEREFORE, YOU DON'T HAVE A CASE. INNOCENT DROPS OF WATER CAN CAUSE MAJOR DAMAGE IF IT'S LEFT IN THE WRONG PLACE OVER A PERIOD OF TIME. DATE OF USE: ONE MONTH IN 2006. DIAGNOSIS OR REASON FOR USE: WOUND HEALING.