INTELECT LEGEND COMBO 4C

Description of Event or Problem

THE PATIENT WAS BEGINNING A TREATMENT WITH HIVOLT ELECTROTHERAPY ON THE ANKLE WHEN SHE COMPLAINED OF A STRONG SHOCK SENSATION IN THE AREA OF TREATMENT. THE THERAPIST REPORTED THAT THE INCIDENT OCCURRED AS THE HIVOLT WAVEFORM WAS BEING SELECTED. THE PATIENT WAS NOT INJURED AND DID NOT REQUIRE MEDICAL ATTENTION.

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 IN HV (SEE FIGURE 4, 5, 6 & 7), NO ANOMALIES WERE FOUND. CONNECTED UNIT TO MYSELF, PREFORMED A HV TREATMENT ON ALL 4 CHANNELS. NO PROBLEM WAS FOUND WHEN SELECTING HV OR WITH THE TREATMENT. IN ACCORDANCE WITH THE MANUAL, SIZE, TYPE, USAGE, AND CONDITION PLAY AN IMPORTANT PART IN THE PROPER DELIVERY OF AN ELECTROTHERAPY. THE ELECTRODES CANNOT 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.