BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICAL GUIDANCE PLATFORM

    MDR report key: 1856257 · Received September 30, 2010

    Report

    Report Number
    2916710-2010-00112
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K071360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY ARE SEEING A GEOMETRY ERROR ON THE LOCALIZATION SCREEN ON OGP AND THE BARS DISAPPEAR GIVING A BLACK SCREEN EXCEPT FOR THE ERROR. THIS OCCURRED DURING PATIENT TREATMENT USING FRAMELESSARRAY ON THE OGP. THIS ISSUE OCCURRED ON THE DISPLAY OF THE OGP SCREEN. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED. NO PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTICAL GUIDANCE PLATFORM ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS OPS

    Patients

    Seq Age Sex Outcome Treatment
    1