BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2935402 · Received January 23, 2013

    Report

    Report Number
    1723686-2013-00001
    Event Type
    Other
    Date Received
    January 23, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ZYNEX MEDICAL INC.
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION TO THE BURN ON THE BACK, THE PATIENT ALLEGES THAT SHE HAD THE UNIT HOOKED UP ON THE BELT CLIP AND SHE TUCKED THE EXCESSIVE LEADWIRES IN HER PANTS AND RECEIVED A BURN WHERE THE LEADWIRES WERE TOUCHING HER SKIN. INVESTIGATION: THE PATIENT STATES THAT SHE RECEIVED BURN SCABS ON HER BACK AND A BURN ON HER STOMACH AREA WHERE THE LEADS WERE TOUCHING. DHR REVIEW REVEALED THAT THE UNIT WAS MANUFACTURED BY ZYNEX ON (B)(6) 2012 WITH DISPLAY BLEED-IN. UNIT PASSED ZYNEX FINAL TESTING AFTER REPAIR FOR A SOLDER BRIDGE. MODE IFC, HI-LO; TIMER: 10 MIN., COMPLIANCE DATA: 45 MIN.; 3 TIMES. UNIT TESTED BY (B)(6), MANUFACTURING TECHNICIAN, ON (B)(6) 2013. THE LEAD WIRES VISUALLY LOOKED GOOD, NO SIGNS OF MELTING OR BURN AREAS. THE DISPLAY WAS CRACKED WHEN RECEIVED. THERE WERE NO ELECTRODES RETURNED WITH THE UNIT. THE UNIT WAS TESTED IN THE TENS MODE AS THE PATIENT HAD IT SET, WITH THE RETURNED LEAD WIRES AND WITH THE STIM AT 30 MA. THE UNIT WAS RUN FOR 2 HOURS IN THAT MODE AND MONITORED FOR ANY HEAD FROM THE LEAD WIRES OR UNIT. THE UNIT TESTED NORMALLY WITH NO HEAT FELT ON THE LEAD WIRES AND NORMAL AMOUNT OF HEAT FROM THE UNIT. THE UNIT THEN WAS TESTED PER THE MANUFACTURING FINAL TEST PROCEDURE AND PASSED. CONCLUSION: THE UNIT PERFORMED CORRECTLY WITHOUT ANY FAILURES OBSERVED.

    Description of Event or Problem · 1

    PATIENT REPORTED SHE RECEIVED A BURN ON HER BACK AND ON HER STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33354 ZYNEX COMBO ELECTRICAL STIMULATOR GZJ ZYNEX MEDICAL INC. NEXWAVE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other