BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2030177 · Received March 15, 2011

    Report

    Report Number
    1723686-2011-00003
    Event Type
    Other
    Date Received
    March 15, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ZYNEX MEDICAL INC.
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE PT SAYS THAT THE UNIT IS SHOCKING HER. DHR REVIEW REVEALED THAT THE UNIT WAS MANUFACTURED BY ZYNEX ON 01/26/2011 WITH NO ISSUES. UNIT PASSED ZYNEX FINAL TESTING WITH NO ISSUES. MODE = IFC, LOW, TIMER: 40 MINS., DATA: 2277 MINS, 64 TIMES. VISUAL INSPECTION OF THE OUTER ENCLOSURE AND ACCESSORIES WAS NORMAL, LEAD WIRES HAVE BLACK ENDS WHICH IS NORMAL AND THAT IS WHAT THE PT WAS DESCRIBING, THERE WAS NO SIGN OF BURN MARKS. MINIMAL WEAR WAS ASSESSED. INSPECTION OF THE PCB SHOWED NO PROBLEMS OR ISSUES, THE UNIT TESTED GOOD. THE UNIT HAS NOT HAD ECO 1142 APPLIED. THIS CORRECTED THE POTENTIAL FOR A SHOCKING SENSATION. AFTER APPLYING ECO 1142 (RE-PROGRAMMED THE PROCESSOR TO 1.60 FIRMWARE), THE UNIT AND ACCESSORIES PASSED THE ZYNEX MEDICAL FINAL TEST PROCEDURE. UNIT RELEASED TO THE SERVICE AREA FOR PROCESSING INTO THE USED INVENTORY. CONCLUSION: THE SHOCKING SENSATION FELT BY THE PT COULD LIKELY HAVE BEEN THE FIRMWARE ISSUE FOUND BY ENGINEERING. CORRECTIVE ACTION: THE FIRMWARE WAS REVISED TO CORRECT THE POTENTIAL OF AN INCREASED STIMULATION SHOCK SENSATION AFTER ONE MIN OF STIMULATION IN THE IFC MODE. ECO (B)(4) WAS IMPLEMENTED ON (B)(6) 2011.

    Description of Event or Problem · 1

    PT REPORTED, SHE GOT A SHOCK WHEN USING THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYNEX TENS ELECTRICAL STIMULATOR GZJ ZYNEX MEDICAL INC. TRUWAVE PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other