BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOMAD PRO

    MDR report key: 4535836 · Received February 20, 2015

    Report

    Report Number
    3005417494-2015-00002
    Event Type
    Malfunction
    Date Received
    February 20, 2015
    Date of Event
    January 20, 2015
    Report Date
    January 20, 2015
    Manufacturer
    ARIBEX, INC.
    Product Code
    EHD
    PMA / PMN Number
    K081664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED IN 09/2012. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION ON 01/26/2015. INVESTIGATION OF THE DEVICE FOUND EVIDENCE OF HEAVILY APPLIED DENTAL OFFICE CLEANERS AND FLUID INGRESS INTO THE INTERIOR OF THE HANDSET WHICH RESULTED IN A THERMAL EVENT. THE THERMAL EVENT WAS CONTAINED IN THE HANDSET ENCLOSURE AND NO INJURIES WERE REPORTED. THE NOMAD PRO OPERATOR MANUAL WARNS USERS THAT CONNECTING AREAS OF THE DEVICE ARE OPEN DIRECTLY ON THE DEVICE. THIS CONCLUDES OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE HANDSET HAD MELTED ONTO THE CHARGING CRADLE. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120966 NOMAD PRO EXTRAORAL SOURCE X-RAY SYSTEM EHD ARIBEX, INC. FP-0005

    Patients

    Seq Age Sex Outcome Treatment
    1