BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE DESK TOP 5.0

    MDR report key: 810993 · Received November 22, 2004

    Report

    Report Number
    9617016-2004-00021
    Event Type
    Malfunction
    Date Received
    November 22, 2004
    Date of Event
    November 1, 2004
    Report Date
    November 22, 2004
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A RISK IF THIS FAILURE GOES UNNOTICED, OR DOUBT ARISES, A FURTHER DELIVERY OF THAT SAME FIELD MAY RESULT IN AN OVERDOSE. IT WOULD STILL BE POSSIBLE TO VERIFY DELIVERY OF THE FIELD BY LOOKING AT THE LINAC RECORD AND USING THE LCD DOES DISPLAY ON THE LINAC CONTROL SYSTEM. WHILE THE RELATIVE FREQUENCY OF THIS ISSUE OCCURRING IS EXTREMELY LOW, ELEKTA HAS ISSUED AN IMPORTANT NOTICE TO CUSTOMERS USING DESKTOP PRO (RELEASE 5.0). THE INVESTIGATION IS ONGOING, A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS CONCLUDED.

    Description of Event or Problem · 1

    TREATMENT HISTORY MAY NOT BE RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE DESK TOP 5.0 MEDICAL LINEAR ACCELERATOR CONTROL SYSTEM IYE ELEKTA LIMITED MN35-0156 (8213 215 8771) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR