BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOMAD PRO

    MDR report key: 4240007 · Received November 3, 2014

    Report

    Report Number
    3005417494-2014-00003
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 8, 2014
    Report Date
    October 7, 2014
    Manufacturer
    ARIBEX, INC.
    Product Code
    EHD
    PMA / PMN Number
    K081664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDSET WAS RECEIVED AND INSPECTED. OUR RECORDS INDICATE THAT THE HANDSET AND THE DEVICE WERE ASSEMBLED (B)(6) 2012. EXPECTED END OF LIFE FOR THE BATTERY IS 300 CHARGE/DISCHARGE CYCLES AS PER THE USER MANUAL. THE UNIT WAS INSPECTED AND IT WAS DETERMINED THAT THE FAILURE WAS DUE TO AN OVER-DISCHARGE OF THE BATTERY THAT LED TO A THERMAL EVENT. THE HEAT FROM THE BATTERY FAILURE LED TO SMALL BURN MARKS ON THE INSIDE BOTTOM OF THE HANDSET. THE BATTERY HANDSET ENCLOSURE WAS NOT COMPROMISED. THERE WERE NO INJURIES REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BATTERY PACK (HANDSET) OF THE UNIT STARTED SMOKING ON CHARGING CRADLE. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704039 NOMAD PRO EXTRAORAL SOURCE X-RAY SYSTEM EHD ARIBEX, INC. FF-0005

    Patients

    Seq Age Sex Outcome Treatment
    1