BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE DESKTOP 4.1

    MDR report key: 510794 · Received January 16, 2004

    Report

    Report Number
    9617016-2004-00003
    Event Type
    Malfunction
    Date Received
    January 16, 2004
    Date of Event
    November 5, 2003
    Report Date
    January 16, 2004
    Manufacturer
    ELEKTA LTD.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FIELDS DELIVERED FROM THE LINEAR ACCELERATOR WERE NOT REPORTED BACK IN A SAFE MANNER TO THE IMPAC SYSTEM, THIS RESULTED IN THE LOSS OF TREATMENT HISTORY WITHIN THE IMPAC SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE DESKTOP 4.1 MEDICAL LINEAR ACCELERATOR CONTROL SYSTEM IYE ELEKTA LTD. RT DESKTOP, R4.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other