RICHMAR

Additional Manufacturer Narrative

BASED ON EVALUATION TESTING OF THE DEVICE, THERE IS NO PROBLEM WITH THE DEVICE AS IT MEETS ALL FUNCTIONAL TEST SPECIFICATIONS. THE ELECTRODE; LEAD WIRES; ACCESSORIES IN USE WITH THE DEVICE DID SHOW HEAVY WEAR AND UNEXPECTED CHANGES IN "RESITANCE" WHEN MEASURED. THE RESITANCE CHANGE IN THE WIRE WOULD LEAD TO A CHANGE IN OUTPUT OF THE STIMULATOR. THE RESITANCE CHANGE IN THE LEAD WIRE IS THE MOST PLAUSIBLE EXPLANATION FOR THE REPORTED EVENT, AS A CHANGE IN RESITANCE COULD LEAD TO AN UNEXPECTED CHANGE IN OUTPUT TO THE PATIENT, WHICH COULD "CASUE" HIGHER THAN INTENDED ENERGY LEVELS RESULTING IN BURNS. THE "MANUFCATURE" PUBLISHES LEAD CORD "MAINTENACNE" WITH THE DEVICE AND PROVIDES LABELLING WITH THE LEAD CORDS FOR THE USER TO ADD DATE LEAD CORDS WERE PUT INTO SERVICE AND A "REPLACE BY" DATE ONE YEAR FROM THE IN SERVICE DATE. FURTHERMORE, THE MANUFACTURE RECOMMENDS LEAD CORDS BE TESTED MONTHLY FOR MAINTENANCE. (B)(4).

Description of Event or Problem

DISTRIBUTOR REPORTED THE FOLLOWING STATEMENT TO COMPASS RICHMAR TECHNICAL SERVICE ON 11/14/2018: "PATIENT REPORTED INCREASED INTENSITY DURING TREATMENT. TREATMENT WAS STOPPED AND WOULD NOT RESET. REDNESS NOTED NEXT VISIT. WOUND PROGRESSED TO PRESENT WITH BLACK SCAR. 'PATEINT' REFERED TO PCP WHEN NO SIGNIFICANT HEALING OCCURRED. PT TOLD: FULL-THICKNESS (3RD DEGREE) ELECTRICAL BURNS." LOCATION OF THE INJURY IS ON THE KNEE.