BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDEX GXP DENTAL X-RAY PROCESSOR

    MDR report key: 1701469 · Received May 27, 2010

    Report

    Report Number
    3004115000-2010-00009
    Event Type
    Malfunction
    Date Received
    May 27, 2010
    Date of Event
    April 27, 2010
    Report Date
    April 27, 2010
    Manufacturer
    GENDEX DENTAL SYSTEMS
    Product Code
    EGY
    PMA / PMN Number
    K945682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PROPERTY DAMAGE OR USER INJURY WITH THIS EVENT. THE TOP COVER ASSEMBLY OF THE FILM PROCESSOR CONTAINS A FAN AND HEATER THAT OPERATES DURING THE DRYING OF THE FILM AS PART OF THE X-RAY FILM PROCESSING. THE FAN CREATES THE AIR FLOW OVER THE HEATER FOR DRYING THE X-RAY FILM. THE FAN STOPPED WORKING FOR UNKNOWN REASONS POSSIBLY CONTRIBUTING TO THE OVERHEATING OF THE HEATER UNIT. THE MANUFACTURER HAS REQUESTED RETURN OF THE FAN AND HEATER FROM THE DENTAL OFFICE FOR EVALUATION. THE FILM PROCESSING UNIT HAS BEEN REPAIRED WITH A FAN AND HEATER REPLACEMENT AND IS OPERATIONAL.

    Description of Event or Problem · 1

    THE DOCTOR STATED THAT DURING OPERATION OF THE DENTAL X-RAY FILM PROCESSOR, THE DRYER FAN STOPPED OPERATING WHILE THE HEATER CONTINUED TO OPERATE. THIS RESULTED IN THE HEATER ASSEMBLY OVERHEATING AND STARTING ON FIRE. THE FIRE WAS LOCALIZED TO THE FILM PROCESSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDEX GXP DENTAL X-RAY PROCESSOR DENTAL X-RAY FILM PROCESSOR EGY GENDEX DENTAL SYSTEMS 112-0527G1

    Patients

    Seq Age Sex Outcome Treatment
    1