BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE BIG BORE (EBW)/PRODUCT CODE

    MDR report key: 1288632 · Received January 5, 2009

    Report

    Report Number
    1525965-2009-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2009
    Date of Event
    December 4, 2008
    Report Date
    December 9, 2008
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAK
    PMA / PMN Number
    033357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    A PHYSICIAN WAS PREPARING TREATMENT FOR A PT AND HE DREW MULTIPLE CONTOURS IN TUMORLOC, SAVED CONTOURS, AND EXITED SYSTEM AFTER SAVING DATA. UPON RE-OPENING IMAGES, A WARNING APPEARED STATING THAT SYSTEM WAS TRYING TO RENAME IMAGES MAKING THESE IMAGES NON-USABLE FOR TREATMENT, HOWEVER, OTHER IMAGES WERE USED DURING TREATMENT OF PT. NO DEATH OR SERIOUS INJURY HAS OCCURRED AND NO MALFUNCTION HAS OCCURRED WHICH IS LIKELY TO CAUSE A DEATH OR SERIOUS INJURY. THE EXAMID THAT IS ASSIGNED TO SLICES FOR RECONSTRUCTION ARE SO SIMILAR (0.000000 VS. 0.000061) THAT OCCASIONALLY, SLICES CAN EITHER BE DISCARDED OR INTERLEAVED DURING THE RECONSTRUCTION PHASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE BIG BORE (EBW)/PRODUCT CODE X-RAY CT SCANNER SYSTEM/JAK JAK PHILIPS HEALTHCARE K033357

    Patients

    Seq Age Sex Outcome Treatment
    1