BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2522684 · Received March 8, 2010

    Report

    Report Number
    1723686-2010-00008
    Event Type
    Other
    Date Received
    March 8, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 2, 2010
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE OVERLAY OFFSET WAS THE CAUSE OF THE FAILURE. CORRECTIVE ACTION: NOTIFY THE PRODUCTION PERSONNEL AND THE CONTRACT MFR, (B)(4), ON THIS PROBLEM.

    Description of Event or Problem · 1

    PT REPORTED THAT THE UNIT WAS INCREASING INTENSITY BY ITSELF AND HAD TO REMOVE THE BATTERY TO GET IT TO SHUT OFF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other