Description of Event or Problem · 1
CUSTOMER STATES UNIT CAUSED A BURN ON A RESIDENTS LOWER BACK. CUSTOMER WANTED TO MAKE NOTE THAT AT THE TIME OF THE INCIDENT, THE MACHINE TURNED ITSELF OFF AND SHOWED AN ERROR MESSAGE. LOOKING AT THE MANUAL, I BELIEVE IT WAS THE ERROR, "THE OUTPUT CURRENT EXCEEDS THE SETTING CURRENT VALUE." I HAD NOT SEEN THIS ERROR CODE BEFORE. AFTER SEEING THIS MESSAGE, THE DEVICE WAS RESTARTED AND THE TREATMENT WAS CONTINUED FOR 8 MORE MINUTES AT 53V. WHEN THE ELECTRODE PADS WERE REMOVED, THERE WAS NO EVIDENCE OF ABNORMALITY ON THE SKIN. THE ELECTRODES USED WERE VALUTRODE, REF #CF5050. THEY ALSO WANTED TO EMPHASIZE THAT THE PACK WAS NEW FOR THAT TREATMENT. THE MACHINE WAS OPERATED BY A PHYSICAL THERAPIST. RELEVANT MEDICAL CONDITIONS: S/P CERVICAL AND LUMBAR LAMINECTOMIES W/ HISTORY OF SEVER STENOSIS C2-C5. THE BURNS ARE DESCRIBED AS '4 FULL-THICKNESS BURNS UNDER PLACEMENT OF ELECTRODES. THE INTERFERENTIAL WAVEFORM WAS BEING USED AT INTENSITY OF 64 MILLIAMPS WITH NO MODULATED PULSE. THE LEADS HAD NOT BEEN REPLACED IN THE LAST 6 MONTHS. NO OINTMENT OR SOLVENT WAS APPLIED PRIOR TO ELECTRODES. THE DEVICE WAS POWERED DOWN WHEN THE ELECTRODES WERE MOVED. THE HAVE READ THE INSTRUCTION MANUAL. THE BURNS ARE ONGOING, 2 WEEKS, AND THE PATIENT WAS REFERRED TO A WOUND SPECIALIST BY A NURSE. THEY WERE USING 4 ELECTRODES THAT WERE ABOUT 4 INCHES APART. FURTHER CLARIFIES THE SETTING AS '64V AT PRESET SETTINGS: 80HZ - 150HZ FOR 1 MINUTE. THE PATIENT DID NOT HAVE METAL IMPLANTS, AS FAR AS THE END USER IS AWARE. 'THE ELECTRODES USED WERE 2" X 2" CLOTH SQUARE VALUTRODE ELECTRODES. ALL FOUR WERE PLACED 1.5" BILATERALLY OF THE SPINAL COLUMN AT LEVEL L3-L5, APPROXIMATELY 3 INCHES APART VERTICALLY.