• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFE FORCE LIFE FORCE HYPERBARIC CHAMBER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIFE FORCE LIFE FORCE HYPERBARIC CHAMBER Back to Search Results
Event Date 03/14/2011
Event Type  Injury  
Event Description

The device is patent pending. It was used on pt by her doctor. It is a chamber that is supposed to work on the sympathetic and parasympathetic nervous system, balancing them. "non invasive 21st century alternative healing technology that combines the light, color spectrum and vibrational sound frequency modulation. This creates an environment within a chamber that encourages the human body into a state of total relaxation. " pt has an autonomic neuropathy in her foot. She did not want to go to a pain clinic so she went to an alternative practitioner. They suggested this device. The first time was (b)(6) 2011 and there was no problem. On (b)(6) 2011, she had second treatment and as soon as the machine went on, she began to have pain in her whole spine, knee, foot and base of head. She was in the machine for 55 minutes of her 60 minute treatment. She was shaking in pain. The dr was not there that day and she saw the assistant. Pt was sent to a room to relax and given fluids. She fell to sleep. Four to five hours later, the dr came in and prescribed ultram. She had terrible pain all night long. She took other pain meds and none worked. The next morning, she felt lumps down her spine and on right side of head (frontal lobe), back of head and multiple lumps at base of skull. No one has helped her. She was seen by a chiropractor who did not acknowledge anything she has. Pt has all of the documentation of what she has had done. An echocardiogram (b)(6) 2011 was negative. She returned to the dr and suggested she go into the machine again, changing the color from violet to green (which should be more relaxing). It was not as bad as the second time. Pt was given 2 meds for stress (a drop and a spray). On (b)(6) 2011, she felt dizzy. The next day, she was dizzy and fell. That night she went to the er for pain. All xrays were negative, she was given medications in the hospital and she felt drugged. She lost track of time and was there 2 days. She saw her dr but he didn't have her records. From (b)(6) 2011, she was seeing physicians. Her lymphnodes are enlarged and her thyroid was not functioning properly. The dr saw her and gave her a small amount of medicine for her thyroid. He also agreed she has heart enlargement. On (b)(6) 2011, pt returned to the er and echocardiogram was positive. A ct scan of the head was "fine". Pt is still in pain and she cannot find a dr to help her. Pt believes this is "quackery. " she has bags of supplement she has been given. She now has high blood pressure with it being 25 mg/hg higher in left from right.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIFE FORCE
Type of DeviceHYPERBARIC CHAMBER
Manufacturer (Section D)
LIFE FORCE
tampa FL
MDR Report Key2382463
Report NumberMW5023476
Device Sequence Number1
Product CodeCBF
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 12/19/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 12/19/2011 Patient Sequence Number: 1
-
-