BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDEX 765DC INTRAORAL X-RAY SYSTEM

    MDR report key: 2242311 · Received September 10, 2011

    Report

    Report Number
    3004115000-2011-00016
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 11, 2011
    Manufacturer
    GENDEX DENTAL SYSTEMS
    Product Code
    EHD
    PMA / PMN Number
    K992610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO USER OR PATIENT INJURY WITH THIS INCIDENT. THE X-RAY UNIT WILL NOT BE REPAIRED. THE OFFICE WILL BE REPLACING THE UNIT WITH A NEW X-RAY UNIT. THE MANUFACTURER HAS REQUESTED RETURN OF THE ARM FOR INSPECTION.

    Description of Event or Problem · 1

    THE HYGIENIST WAS POSITIONING THE TUBEHEAD OF THE X-RAY UNIT FOR AN X-RAY WHEN THE INTERNAL WORKINGS OF THE ARTICULATED ARM BROKE LOOSE CAUSING THE ARM TO DROP DOWN. THE HYGIENIST WAS ABLE TO CATCH THE ARM AND TUBEHEAD FROM FALLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDEX 765DC INTRAORAL X-RAY SYSTEM DENTAL X-RAY EQUIPMENT EHD GENDEX DENTAL SYSTEMS 765DC

    Patients

    Seq Age Sex Outcome Treatment
    1