BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOMAD PRO

    MDR report key: 4181161 · Received October 14, 2014

    Report

    Report Number
    3005417494-2014-00002
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ARIBEX, INC.
    Product Code
    EHD
    PMA / PMN Number
    K935046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDSET WAS RECEIVED AND INSPECTED WHERE IT WAS DETERMINED THAT 2 SMALL HOLES (APPROXIMATELY 1/2 INCH IN DIAMETER) HAD BEEN BURNED THROUGH THE BOTTOM OF THE HANDSET. OUR RECORDS INDICATE THAT THE HANDSET AND DEVICE WERE ASSEMBLED IN (B)(6) 2012 AND ARE ABOUT 2 YEARS OLD. EXPECTED END OF LIFE FOR THE HANDSET IS 300 CHARGE/DISCHARGE CYCLES AS PER THE USER MANUAL. UPON FURTHER INSPECTION, IT WAS DETERMINED THAT THE BATTERY EXPERIENCED A THERMAL RUNAWAY WHICH LED TO A BATTERY FAILURE IN THE DEVICE. THIS FAILURE BURNED THE SMALL HOLES (APPROXIMATELY 1/2 INCH IN DIAMETER) IN THE BOTTOM OF THE HANDSET. THERE WAS NO DAMAGE TO THE SURROUNDINGS AND THERE WERE NO PT INJURIES REPORTED. THIS COMPLETES OUR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT THE DEVICE CONTACT BROKE AND THE DEVICE BATTERY WAS LEFT ON THE UNIT OVERNIGHT AND WAS PARTIALLY BURNED WHEN FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649750 NOMAD PRO EXTRAORAL SOURCE X-RAY SYSTEM EHD ARIBEX, INC. FP-0005

    Patients

    Seq Age Sex Outcome Treatment
    1