BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-BOARD IMAGER (OBI)

    MDR report key: 2104825 · Received May 17, 2011

    Report

    Report Number
    2916710-2011-00051
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K040192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY RESULT IN SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE OBI WORKSTATION HAD A DIFFERENT "ACTUAL" VALUE THAN THE CLINAC SOFTWARE. E.G. THE CLINAC SOFTWARE WAS SHOWING AN ACTUAL OF 119.7 AND OBI WS HAD AN ACTUAL OF 139.9. THE TARGET VALUE IN OBI WORKSTATION WAS SET TO 119.7. THE CALCULATED SHIFT WAS CORRECT FOR THE DATA SHOWN ON THE OBI WORKSTATION, HOWEVER, IT COULD BE SEEN, THAT ON THE OBI WORKSTATION AND CLINAC, THAT THE TWO ACTUALS DID NOT AGREE (CUSTOMER SUPPLIED SCREEN-SHOTS). THE CUSTOMER THEN RESTARTED THE OBI WORKSTATION SOFTWARE, CLOSED AND RELOADED THE PATIENT AND REIMAGED; REBOOT OF THE WORKSTATION RESOLVED THE PROBLEM. THERE WAS NO MISADMINISTRATION OR SERIOUS INJURY REPORTED ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-BOARD IMAGER (OBI) ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H08

    Patients

    Seq Age Sex Outcome Treatment
    1