BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE DIGITAL ACCELERATOR

    MDR report key: 5350469 · Received September 10, 2004

    Report

    Report Number
    9617016-2004-00012
    Event Type
    Malfunction
    Date Received
    September 10, 2004
    Date of Event
    July 26, 2004
    Report Date
    September 10, 2004
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN OF THE FAULTY TRANSFORMER, THE INVESTIGATION WILL BEGIN TO DETERMINE CAUSE OF FIRE AND TRANSFORM FAILURE. ON COMPLETION OF INVESTIGATION, THE CONCLUSION WILL BE MADE AVAILABLE IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    WHILE IN SERVICE MODE CUSTOMER HEARD A NOISE FROM BEHIND THE FACIAL WALL. UPON INVESTIGATION, THE CUSTOMER DISCOVERED TRANSFORMER T13 SMOKING AND A SMALL FLAME ON THE FILTER BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE DIGITAL ACCELERATOR DIGITAL LINEAR ACCELERATOR IYE ELEKTA LIMITED MRT 6001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UK