ZYNEX

Description of Event or Problem

PATIENT REPORTED SEVERE PAIN DUE TO THE UP STIM BUTTON WAS STUCK, AND A "BURN" OCCURRED ON HER SKIN UNDER THE ELECTRODES.

Additional Manufacturer Narrative

NO VISUAL DEFECTS OBSERVED. DHR REVIEW REVEALED THAT THE UNIT WAS MANUFACTURED BY ZYNEX ON (B)(4) 2010 WITH NO ISSUES. MODE=TENS, SWEEP:, TIMER: 50 MIN. UNIT TESTED BY (B)(4), MANUFACTURING TECHNICIAN ON (B)(4) 2010. THE DEVICE SELECTED IS 'TENS' AFTER TURNING ON THE UNIT. THE "UP" ARROW BUTTON FOR CHANNEL 2 WOULD STICK AFTER TRYING TO RAMP UP CHANNEL 2. HE REMOVED BUTTON OVERLAY MATERIAL THAT HAD BEEN OBSTRUCTING THE RANGE OF MOTION FOR THE BUTTON. THIS IS THE FIRST INCIDENT OF THIS TYPE FOR THIS PRODUCT. THE UNIT WAS THEN TESTED PER THE FINAL TEST PROCEDURE AND PASSED ALL TESTS. UNIT RELEASED TO THE SERVICE AREA FOR PROCESSING INTO THE USED INVENTORY. CONCLUSION: ASSEMBLY ERROR, THE EXCESS MATERIAL IN THE BUTTON HOLE WAS THE CAUSE OF THE FAILURE BECAUSE, THE OVERLAY WAS SLIGHTLY OFF CENTER. CORRECTIVE ACTION: THE ASSEMBLERS WERE NOTIFIED TO CHECK FOR THIS OVERLAY MATERIAL OBSTRUCTING ANY BUTTON MOVEMENT. SEE SCANNED PAGE.