BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOMAD PRO

    MDR report key: 4071212 · Received September 2, 2014

    Report

    Report Number
    3005417494-2014-00001
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    July 24, 2014
    Report Date
    August 30, 2014
    Manufacturer
    ARIBEX, INC.
    Product Code
    EHD
    PMA / PMN Number
    K935046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDSET AND THE DEVICE WERE ASSEMBLED ON 17-OCT-2011 AND IS ABOUT 3 YEARS OLD. EXPECTED END OF LIFE FOR THE HANDSET IS 2 YEARS OR 300 CHARGE/DISCHARGE CYCLES. THE BATTERY PACK (HANDSET) WAS BEYOND END OF LIFE SINCE THE BATTERY WAS OVER 2 YEARS OLD. ADDITIONAL INVESTIGATION IS ONGOING AND A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BATTERY PACK (HANDSET) OF THE DEVICE CAUGHT FIRE WHILE PLACED IN A DRAWER AND PARTIALLY MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532451 NOMAD PRO EXTRAORAL SOURCE X-RAY SYSTEM EHD ARIBEX, INC. FP-0005

    Patients

    Seq Age Sex Outcome Treatment
    1