BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-BOARD IMAGER (OBI)

    MDR report key: 1928859 · Received November 29, 2010

    Report

    Report Number
    2916710-2010-00135
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 2, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K041519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A MALFUNCTION IN THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED PT "A" DISPLAYED IN OBI WHEN PT "B" IS MODED UP ON 4DITC. USER HAD THE FOLLOWING PT MODED UP ON THE 4D (ID (B)(4)) HOWEVER, THE OBI SHOWED A PREVIOUS PT THAT WAS TREATED EARLIER (ID (B)(4)). THEY CALLED THE MANAGER AND BY THE TIME SHE GOT THERE, THEY WERE SELECTING OPTIONS ON THE OBI AND THE OBI WORKSTATION REFRESHED AND EVENTUALLY SHOWED THE CORRECT PT. THERE WAS NO REPORT OF INJURY TO THE PT AND NO PT DATA WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1