RICH-MAR WINNER CM2

Description of Event or Problem

PT WAS BURNED AFTER RECEIVING 15 MINS OF RUSSIAN ELECTRICAL STIMULATION. PT DID NOT REPORT ANY DISCOMFORT AT ANY TIME DURING TREATMENT.

Additional Manufacturer Narrative

ON (B)(6) 2012, (B)(6) OF (B)(6) CONTACTED THE RICH-MAR SERVICE DEPT CONCERNING A BURN INCIDENT IN WHICH A RICH-MAR WINNER CM2 WAS INVOLVED. AT THAT TIME, (B)(6) WAS SENT THE "RICH-MAR MEDICAL DEVICE REPORTING - FACILITY REPORT" ((B)(4)) TO BE COMPLETED AND RETURNED TO THE REGULATORY AFFAIRS (B)(4). ON (B)(6) 2012, (B)(6) FAXED THE REPORT TO RICH-MAR TO THE ATTENTION OF (B)(4) OF THE SERVICE DEPT INSTEAD OF THE REGULATORY AFFAIRS (B)(4). ON (B)(6) 2012, THE FAXED REPORT WAS GIVEN TO THE REGULATORY AFFAIRS (B)(4). THE REPORT SENT TO RICH-MAR FROM (B)(6) OFFERED LIMITED INFO CONCERNING THE INCIDENT. ON (B)(4) 2012, THE WINNER CM2 WAS RECEIVED AT RICH-MAR FOR EVALUATION. ALONG WITH THE WINNER CM2 DEVICE, THE TWO (2) ELECTRODES USED ON THE PT AT THE TIME OF THE INCIDENT WERE ALSO SENT TO RICH-MAR. THE ELECTRODES ARE DURA-STICK 2" X 2" SQUARE MANUFACTURED BY CHATTANOOGA GROUP. EVALUATION OF THE ELECTRODES WAS DONE WITH THE FOLLOWING RESULTS: VISUAL INSPECTION SHOWS A BURNT CORNER ON EACH OF THE ELECTRODES. PEEL TESTING WAS DONE TO DETERMINE THE STRENGTH OF THE SELF ADHESIVE GEL, MEASURED IN FOOT POUNDS, ON EACH OF THE ELECTRODES. THIS TEST WAS REPEATED 3 TIMES TO DETERMINE THE AVERAGE PEEL STRENGTH. "ELECTRODE 1" AVERAGE PEEL STRENGTH WAS 1.7 FOOT POUNDS WHILE "ELECTRODE 2" AVERAGE PEEL STRENGTH WAS 0.6 FOOT POUNDS. THE RICH-MAR WINNER CM2 DEVICE WAS EVALUATED AND FOUND TO OPERATE PROPERLY AND WITH IN THE SPECIFICATIONS OUTLINED IN 510(K): K013771.