BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2253161 · Received August 31, 2011

    Report

    Report Number
    1723686-2011-00007
    Event Type
    Other
    Date Received
    August 31, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE'S CIRCUIT BOARD WAS DAMAGED BY THE USER, THE CIRCUIT BOARD COULD NOT BE REPAIRED AND HAD TO BE SCRAPPED. INVESTIGATION: THE PATIENT STATED THAT THE UNIT BURNED HER IN TWO AREAS ON HER LOWER BACK WHERE THE ELECTRODES WERE PLACED. DHR REVIEW REVEALED THAT THE UNIT WAS MANUFACTURED BY ZYNEX ON (B)(6) 2011, WITH NO ISSUES. UNIT PASSED ZYNEX FINAL TESTING WITH NO ISSUES. NO COMPLIANCE DATA AVAILABLE. UNIT TESTED BY (B)(6), MANUFACTURING TECHNICIAN, ON (B)(6) 2011. THE UNIT WOULD NOT TURN ON. WHEN THE UNIT WAS OPENED, THERE WAS A COMPARTMENT (U18) LAYING LOOSELY IN THE ENCLOSURE. HE NOTICED THAT THERE WERE SOME COMPONENTS MISSING AT THE BOTTOM OF THE BOARD, R65, C43, C48, NEAR WHERE THERE WERE SEVERAL MARKS ON THE BOARD ITSELF. THIS AREA IS WHERE THERE IS AN OPENING IN THE ENCLOSURE FOR THE BATTERY COVER TO FIT IN. THE LEAD WIRES WERE RETURNED WITH THE UNIT AND TESTED GOOD BUT THE ELECTRODES WERE NOT RETURNED. THERE IS NO WAY TO CONFIRM IF THERE WAS ANY PROBLEM WITH THE UNIT SINCE IT HAD DAMAGE TO THE BOARD THAT RENDERED IT INOPERABLE. THE BOARD WAS TOO DAMAGED TO REPAIR AND SO THE UNIT WILL BE SCRAPPED. CONCLUSION: THIS FAILURE OF THE UNIT WAS DUE TO CUSTOMER ABUSE. WE COULD NOT VERIFY ANY PROBLEM WITH THE ELECTRODES SINCE THEY WERE NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SHE RECEIVED BURNS IN TWO PLACES ON HER LOWER BACK WHERE ELECTRODES WERE PLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other