BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOMAD PRO

    MDR report key: 4451339 · Received January 23, 2015

    Report

    Report Number
    3005417494-2015-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2015
    Date of Event
    December 23, 2014
    Report Date
    December 23, 2014
    Manufacturer
    ARIBEX, INC.
    Product Code
    EHD
    PMA / PMN Number
    K081664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS ASSEMBLED 30-APRIL-2012. THE INITIAL INCIDENT WAS REPORTED TO THE MFR ON (B)(4) 2014. BASED ON THE AVAILABLE INFO AT THAT TIME, THE INCIDENT WAS DETERMINED TO BE NOT REPORTABLE. UPON RECEIPT AND INSPECTION OF THE DEVICE HANDSET AND CHARGER, THE DATE OF AWARENESS WAS ESTABLISHED AS (B)(4) 2014 AND THE DETERMINATION WAS MADE TO REPORT THIS INCIDENT. THE INVESTIGATION 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 TO INGRESS, AND DAMAGE MAY OCCUR IF CLEANERS ARE SPRAYED DIRECTLY ON THE DEVICE. THIS CONCLUDES OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE HANDSET CASING WAS PARTIALLY MELTED AND THE CHARGING CRADLE HAD CHARRING ON THE CONTACTS. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53701 NOMAD PRO EXTRAORAL SOURCE X-RAY SYSTEM EHD ARIBEX, INC. FP-0005

    Patients

    Seq Age Sex Outcome Treatment
    1