BEUDAMED
    FDA Adverse Event Other Summary report: N

    SL SERIES - JAVELIN 3.2.0(CONTROL SYSTEM)

    MDR report key: 526308 · Received May 21, 2004

    Report

    Report Number
    9617016-2004-00009
    Event Type
    Other
    Date Received
    May 21, 2004
    Date of Event
    March 18, 2004
    Report Date
    May 21, 2004
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER BELIEVES 6 TO 6 PLANNED FIELDS WERE DELIVERED, HOWEVER RECORDS SHOW ONLY 5 OF THE 6 WERE DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SL SERIES - JAVELIN 3.2.0(CONTROL SYSTEM) DIGITAL LINEAR ACCELERATOR IYE ELEKTA LIMITED MRT 0512 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other