BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2453685 · Received February 10, 2012

    Report

    Report Number
    1723686-2012-00001
    Event Type
    Other
    Date Received
    February 10, 2012
    Date of Event
    January 18, 2012
    Report Date
    February 9, 2012
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    IPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DHR REVIEW REVEALED THAT THE UNIT WAS MFG BY ZYNEX ON (B)(4) 2011, WITH NO ISSUES. UNIT PASSED ZYNEX FINAL TESTING WITH NO ISSUES. MODE: IFC, LOW-HIGH; TIMER: 60 MIN., DATA: 1112 MINS, 29 TIMES. UNIT TESTED AND INSPECTED BY (B)(6), ON (B)(4) 2012. OSCILLOSCOPE TEST PERFORMED IN ALL MODES. ALL WAVEFORM LEVELS AND TIMINGS WERE CORRECT AND ACCORDING TO SPECIFICATION. ON-SKIN TEST PERFORMED. ELECTRODES CONNECTED TO UNDERSIDE OF RIGHT FOREARM. TESTED IN LOW-HIGH MODE AT 8 MA OUTPUT. BATTERY POWERED USING PARTIALLY DRAINED ZYNEX BATTERY. WHILE TREATMENT WAS IN EFFECT, TOUCHED CENTER CONDUCTOR OF AC ADAPTER INPUT CONNECTOR. WAS NOT ABLE TO REPLICATE THE PROBLEM. NO SHOCKING SENSATION OCCURRED WHILE PROBING AROUND THE AC ADAPTOR CONNECTOR. CONCLUSION: IT IS INCONCLUSIVE EXACTLY HOW THE PT EXPERIENCED A SHOCKING SENSATION.

    Description of Event or Problem · 1

    PT REPORTED THAT SHE RECEIVED A SHOCK AND A BLISTER ON HER SKIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other