BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2623087 · Received June 14, 2012

    Report

    Report Number
    1723686-2012-00012
    Event Type
    Other
    Date Received
    June 14, 2012
    Date of Event
    May 20, 2012
    Report Date
    June 14, 2012
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE PATIENT STATES THAT SHE GOT A SHOCK FROM THE A/C ADAPTER OUTLET. DHR REVIEW REVEALED THAT THE UNIT WAS MANUFACTURED BY ZYNEX ON (B)(4) 2012, WITH NO ISSUES. UNIT PASSED ZYNEX FINAL TESTING WITH NO ISSUES. MODE IFC, COMBO; TIMER: 90 MIN., DATA: 3056 MINS.; 102 TIMES. UNIT TESTED BY JOE MOORE, MANUFACTURING TECHNICIAN, ON (B)(6) 2012. HE TESTED THE UNIT AS RECEIVED FROM THE PATIENT. HE FOUND THAT THE UNIT PASSED ALL TESTS, NO PROBLEM COULD BE FOUND WITH THE UNIT. THE ELECTRODES WERE NOT RETURNED WITH THE UNIT. CONCLUSION: WE COULD NOT CONFIRM THE PROBLEM DESCRIBED BY THE PATIENT. CORRECTIVE ACTION: NONE REQUIRED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SHE RECEIVED A SHOCK FROM THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYNEX INTERFERENTIAL ELECTRICAL STIMULATOR GZJ ZYNEX MEDICAL, INC. NEXWAVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other