BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GXDP-700

    MDR report key: 2619735 · Received June 5, 2012

    Report

    Report Number
    3005383085-2012-00001
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Date of Event
    February 27, 2012
    Report Date
    May 31, 2012
    Manufacturer
    PALODEX GROUP OY
    Product Code
    MUH
    PMA / PMN Number
    K093683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED SYMPTOM OF CIRCUIT FAILURE AND OR BURNING CIRCUITRY COULD NOT BE DUPLICATED NOR CONFIRMED. VISUAL/PHYSICAL EXAMINATION ACCOMPANIED BY OLFACTORY ODOR DETECTION YIELDED NO EVIDENCE OF FAILED CIRCUITRY OR COMPONENTS CONSISTENT WITH THE REPORTED SYMPTOMS OF BURNING. A FAILURE OF THE DISPLAY WAS FOUND. THE REPORTED SYMPTOM OF GUI DISPLAY FAILURE WAS CONFIRMED. NO PT INVOLVEMENT.

    Description of Event or Problem · 1

    DURING A ROUTINE FOLLOW-UP PHONE CALL ON (B)(6) 2012, TO REQUEST ADDITIONAL INFORMATION ABOUT THE ORIGINAL COMPLAINT WHICH WAS FOR "SMELL OF SMOKE," THE OFFICE REPORTED THAT THE UNIT CAUGHT FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GXDP-700 ORTHOPANTOMOGRAPH OP300 MUH PALODEX GROUP OY

    Patients

    Seq Age Sex Outcome Treatment
    1