BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GX770 INTRAORAL X-RAY SYSTEM

    MDR report key: 1234023 · Received November 19, 2008

    Report

    Report Number
    3004115000-2008-00021
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    GENDEX DENTAL SYSTEMS
    Product Code
    EHD
    PMA / PMN Number
    K935046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO PATIENT OR USER INJURIES WITH THIS EVENT. THE ARM'S CASTING WAS BROKEN AT THE PIVOT POINT WHERE IT GOES INTO THE MASTER CONTROL UNIT. THE HORIZONTAL ARM WILL NEED TO BE REPLACED. UNIT CANNOT BE USED UNTIL IT IS REPAIRED. DEVICE EVALUATED BY DEALER SERVICE TECH.

    Description of Event or Problem · 1

    THE OPERATOR WAS MOVING THE ARM OF THE UNIT BACK TO THE WALL, WHEN THE SCISSOR ARM WITH THE TUBEHEAD BROKE OFF AND FELL ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GX770 INTRAORAL X-RAY SYSTEM DENTAL X-RAY EQUIPMENT EHD GENDEX DENTAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1