BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOMAD PRO

    MDR report key: 4777684 · Received May 15, 2015

    Report

    Report Number
    1017522-2015-00007
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 16, 2015
    Manufacturer
    ARIBEX, INC.
    Product Code
    EHD
    PMA / PMN Number
    K081664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO MANUFACTURER ON 04/28/2015. INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE HANDSET AND THE CHARGING CRADLE WERE PARTIALLY MELTED AND CHARRED. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320094 NOMAD PRO EXTRAORAL SOURCE X-RAY SYSTEM EHD ARIBEX, INC. FP-0005

    Patients

    Seq Age Sex Outcome Treatment
    1