INTELECT 4CH STIM PKG

Additional Manufacturer Narrative

A DEVICE EVALUATION WAS PERFORMED BY OUR ENGINEERING DEPARTMENT. ROOT CAUSE IS UNKNOWN BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE ENGINEERING DEPARTMENT DID NOT FIND ANY PROBLEMS WITH THE DEVICE. THE DEVICE LABELING IDENTIFIES ADVERSE EFFECTS; SKIN IRRITATION AND BURNS BENEATH THE ELECTRODES HAVE BEEN REPORTED WITH THE USE OF POWERED MUSCLE STIMULATORS. CONCLUSION: IFC WAVEFORM DEMONSTRATED PROPER OPERATION OF THE CONTROL AND OUTPUT CIRCUITRY. WHILE THE UNIT MAY GENERATE MANY WAVEFORMS, ALL BUT THE HIGH VOLT (SEE FIGURE 4, 5, 6 & 7), USE THE SAME OUTPUT CIRCUITRY INVOLVED IN THE GENERATION AND DELIVERY ON STIMULATION. SEE FIGURE 2 AND 3. UNIT PASSED ALL TEST CONDUCTED, NO ANOMALIES WERE FOUND. IN ACCORDANCE WITH THE MANUAL, SIZE, TYPE, USAGE, AND CONDITION PLAY AN IMPORTANT PART IN THE PROPER DELIVERY AN ELECTROTHERAPY. THE ELECTRODES HAD VERY LITTLE STICK TO THEM AND CAN'T BE RULED OUT AS A FACTOR REGARDING THE INCIDENT STATED IN THE REPORT. PATIENT SKIN PREPARATION OR ELECTRODE PLACEMENT CAN CONTRIBUTE TO THE REPORTED INCIDENT. THE UNIT MEETS ALL MANUFACTURES SPECIFICATIONS. SEE SCANNED PAGES.

Description of Event or Problem

THE DOCTOR APPLIED AN ELECTROTHERAPY SELF TREATMENT AND EXPERIENCED A BURNING SENSATION UNDER THE TREATMENT ELECTRODES. NO INJURIES WERE REPORTED.

Additional Manufacturer Narrative

A DEVICE EVALUATION WAS PERFORMED BY OUR ENGINEERING DEPARTMENT. ROOT CAUSE IS UNKNOWN BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE ENGINEERING DEPARTMENT DID NOT FIND ANY PROBLEMS WITH THE DEVICE. THE DEVICE LABELING IDENTIFIES ADVERSE EFFECTS; SKIN IRRITATION AND BURNS BENEATH THE ELECTRODES HAVE BEEN REPORTED WITH THE USE OF POWERED MUSCLE STIMULATORS. CONCLUSION: IFC WAVEFORM DEMONSTRATED PROPER OPERATION OF THE CONTROL AND OUTPUT CIRCUITRY. WHILE THE UNIT MAY GENERATE MANY WAVEFORMS, ALL BUT THE HIGH VOLT (SEE FIGURE 4, 5, 6 & 7), USE THE SAME OUTPUT CIRCUITRY INVOLVED IN THE GENERATION AND DELIVERY ON STIMULATION. SEE FIGURE 2 AND 3. UNIT PASSED ALL TEST CONDUCTED, NO ANOMALIES WERE FOUND. IN ACCORDANCE WITH THE MANUAL, SIZE, TYPE, USAGE, AND CONDITION PLAY AN IMPORTANT PAR TIN THE PROPER DELIVERY AN ELECTROTHERAPY. THE ELECTRODES HAD VERY LITTLE STICK TO THEM AND CAN'T BE RULED OUT AS A FACTOR REGARDING THE INCIDENT STATED IN THE REPORT. PATIENT SKIN PREPARATION OR ELECTRODE PLACEMENT CAN CONTRIBUTE TO THE REPORTED INCIDENT. THE UNIT MEETS ALL MANUFACTURES SPECIFICATIONS. SEE SCANNED PAGES.

Description of Event or Problem

DURING AN ELECTROTHERAPY TREATMENT PATIENTS COMPLAINED OF A BURNING SENSATION UNDER THE TREATMENT ELECTRODES. THE DOCTOR APPLIED A SELF TREATMENT AND EXPERIENCED THE SAME SENSATION. NO INJURIES WERE REPORTED. THE DOCTOR COULD NOT RECALL THE NUMBER OF PATIENTS, TREATMENT SYMPTOMS, OR TREATMENT PARAMETERS. THE DOCTOR DID COMMENT THAT HE HAD PROBLEMS WITH THE DEVICE PRIOR TO THIS EVENT, BUT THE DEVICE HAD NOT BEEN IN FOR REPAIR SINCE 2006. PATIENT ONE OF TWO.