BODYSCAN 2010 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-10 for BODYSCAN 2010 * manufactured by Phazx Systems, Inc..

Event Text Entries

[217432] Rptr writes this letter out of concern for the general public rather than to settle any personal grievance. Rptr is also taking this action of rptr's own accord, with no affiliation with or endorsement by the co rptr works for. Rptr's experience is personal and so is this action. Rptr's begins by describing a situation. Recently this spring, rptr's spouse consented to assist their neighbors in practicing with a piece of equipment they had recently purchased and attended formal, required training for. The piece of equipment is the bodyscan 2010 made by phazx systems, inc. There was no pain or discomfort and neighbor is not seeking any action of own accord. The bodyscan cost the neighbor's on the order of thirty thousand dollers, of which their formal training was a part. The process consists of taking electrical readings from the body and storing them in a computer. This computer then provided a report of what body systems are mis-aligned and what chemical substances in the form of herbal remedies, in which amounts would correct the imbalance. The person giving the exam then prepares a bottle of liquid which is placed on/in the machine. The pt is then instructed to take this liquid by mouth with instructions resembling a prescription. Once spouse participated in this process, spouse described it to rptr in detail. Soon afterward, they inquired of the neighbors for more info. The answers that they obtained from phazx were of the sort that indicated that something was not on the up and up. So rptr began to look into phazx and the bodyscan 2010. Allow rptr to digress at this point. Rptr works for a co that specialized in electrical testing for the mass market. They support customers. A full 75% of all of the wire mfg in the world is tested using the co's equipment. One of the engineers is pursuing a phd and has a grant from the faa to help solve the aging aircraft wiring problem. Rptr has no issue with the biofeedback portion of the product. The issue rptr raises is with the part of the process where a fluid is placed in/on the machine and by some electrical process, the characteristics of that fluid is purportedly changed to give the user something to take orally that would benefit them. Frankly, this is impossible. The process is akin to transforming water into wine. The only way that a fluid would retain any characteristics that were electrically passed to it would be for the ph to change, creating a known poison. Although water and other fluids conduct electricity and respond magnetically, they are incapable on maintaining the affected state away from the electrical currents being applied to them for more than a second. Additionally, the fluid is encased in a glass bottle, a very well known electrical insulator. Even with the lid off the bottle, the voltage or current necessary to pass through the glass would be enough to deliver serious shock hazard to the operator. Even at that voltage, they claimed enough to deliver serious shock hazard to the operator. Even at that voltage, the claimed effect on the fluid is not only improbable, but impossible. Again, any change that any fluid could maintain would have to be the result of a chemical process that would alter the composition of the substance, a dangerous prospect if it were possible with their equipment. Rptr strongly suggests that this part of their process is a ruse, cleverly designed to dupe the general public and the practitioners that utilize their product. There is a body of research and evidence contrary to the pahzx claims. Numerous college textbooks as well as professional literature describe the characteristcs of fluids under the effects of electricity. Rptr also has an issue with using the electrical readings to diagnose and offer treatment of bodily conditions by recommending combinations of herbal treatments as remedies. Rptr is aware that rptr makes a serious accusation. Rptr has seen the disclaimers that this equipment is not used for diagnosis. If fda reviews the training that the practitioners receive, which is mandatory, and the actual function of the machine itself, the fda will find that diagnosis is an integral part of their process. Rptr believes even a casual review and test of the phazx bodyscan equipment will reveal the extend to which they are deceiving the public and discrediting the medical establishment. Since expressing rptr's doubts and reasoning, the neighbors have been unwilling to give out the report that paying customers receive unless, the rptr's were to become paying customers, or it would be attached. Rptr has contacted pyazx three times requesting info. The first two times rptr spoke with an individual. The last time was the 21 of sept, 2001, where rptr spoke with another individual in accounting. In all three cases, the people rptr spoke to offered to have the owner/developer of the co/product contact rptr with info regarding any research that could prove that the bodyscan unit could actually accomplish its claims. The individual said that such research existed the first time rptr called but retracted the comment the second time. The other individual took all of rptr's info again and promised that something would be sent. Obviously, nothing has been presented to rptr. Rptr hopes that this letter is sufficient to have some oversight action taken to stop phazx from promoting, distribution, or use of the portion of its process and equipment that is clearly a deception, whether knowing or unknowing. Rptr is also interested in the fda's findings.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1023098
MDR Report Key356337
Date Received2001-10-10
Date of Report2001-10-10
Date Added to Maude2001-10-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBODYSCAN 2010
Generic NameBIOFEEDBACK DIAGNOSTIC TOOL
Product CodeHCC
Date Received2001-10-10
Model Number2010
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key345563
ManufacturerPHAZX SYSTEMS, INC.
Manufacturer Address711 N TEJON COLORADO SPRINGS CO 80903 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2001-10-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.