BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 64

    MDR report key: 2833804 · Received November 5, 2012

    Report

    Report Number
    1525965-2012-00089
    Date Received
    November 5, 2012
    Report Date
    October 9, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT PR# (B)(4). INITIAL MDR MAILED ON (B)(4), 2012.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A CUSTOMER COMPLAINT THAT A BRAIN CT WAS INTERPRETED AS A BLEED BY THE RADIOLOGIST. A REPEAT SCAN ON A DIFFERENT CT SYSTEM DETERMINED PATHOLOGY AND THE IMAGES DID NOT SHOW A BLEED. THE IMAGES FROM THE REPEAT SCAN CONFIRMED THE PT DID NOT HAVE A INTRACRANIAL BLEED AND THE CUSTOMER SUSPECTS THE ORIGINAL CT IMAGES REPRESENT AN ARTIFACT. THE PT DID NOT EXPERIENCE ANY MISTREATMENT DUE TO THE ORIGINAL INTERPRETATION. INITIAL INVESTIGATION DETERMINED THAT THE SYSTEM DID NOT MALFUNCTION AND USER ERROR COULD HAVE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1