BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 3037250 · Received March 18, 2013

    Report

    Report Number
    1723686-2013-00003
    Event Type
    Other
    Date Received
    March 18, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    MHY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE PATIENT STATES THAT SHE RECEIVED BLISTERS ON HER BACK. DHR REVIEW REVEALED THAT THE UNIT WAS MANUFACTURED BY ZYNEX ON 05/20/2011 WITH HIGH CURRENT FAILURE. UNIT PASSED ZYNEX FINAL TESTING AFTER REPAIR. MODE IFC, LOHI; TIMER: 60 MIN. COMPLIANCE DATA: 1183 MIN.; 91 TIMES. UNIT TESTED BY (B)(4), LEAD SERVICE TECHNICIAN, ON (B)(4) 2013. HE TESTED THE UNIT AS RECEIVED. THE UNIT WAS TESTED USING PATIENT ELECTRODES AND LEAD WIRES. ELECTRODE TESTER CONSISTED OF TWO (B)(4) RESISTOR CONNECTED BETWEEN THEM. ONE PAIR OF KNOWN GOOD, REFERENCE, ELECTRODES WAS ATTACHED TO THE FRONT SIDE OF THE PLATES. THE PATIENT ELECTRODES UNDER TEST WERE ATTACHED TO THE UNDERSIDE OF THE PLATES. BOTH PAIR OF PATIENT ELECTRODES WERE TESTED, ONE PAIR AT A TIME. POWER WAS SUPPLIED WITH AN AGILENT MODEL E3611A POWER SUPPLY. POWER SUPPLY WAS SET FOR 12 VDC, 1000 MA. POWER WAS SUPPLIED THROUGH THE ADAPTER JACK ON THE SIDE OF THE DEVICE. CONCLUSION: PATIENT UNIT TESTED NORMALLY. PATIENT ELECTRODES PERFORMED SIMILAR TO REFERENCE ELECTRODES USING METAL ELECTRODE TEST JIG. PATIENT ELECTRODE CHARACTERISTICS MATCHED VERY CLOSELY PAIR TO PAIR.

    Description of Event or Problem · 1

    PATIENT REPORTED SHE HAD A BURNING SENSATION AND THEN NOTICED TWO BLISTERS ON HER BACK WHERE THE ELECTRODES WERE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111887 ZYNEX ELECTRICAL STIMULATOR MHY ZYNEX MEDICAL, INC. TRUWAVE PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other