BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2614422 · Received June 6, 2012

    Report

    Report Number
    1723686-2012-00010
    Event Type
    Other
    Date Received
    June 6, 2012
    Date of Event
    May 17, 2012
    Report Date
    June 6, 2012
    Manufacturer
    ZYNEX MEDICAL INC.
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PROCESSOR LIKELY WAS CORRUPTED. THIS FAILURE OF THE PROCESSOR DID NOT HAVE A DIRECT IMPACT ON THE PT'S INJURY, THE TIMER FUNCTION WAS WORKING PROPERLY AND UNIT WOULD HAVE SHUT DOWN IN 90 MIN, AND THE TREATMENT SET FOR THE PT WAS IFC. CORRECTIVE ACTION: NONE REQUIRED, UNK WHAT CAUSED THE PROCESSOR TO GET STUCK IN IFC COMBO.

    Description of Event or Problem · 1

    PT REPORTED THAT SHE RECEIVED A QUARTER SIZE BURN/BLISTER IN THE LUMBAR REGION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other