BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 40 SLICE CT SCANNER

    MDR report key: 969245 · Received December 21, 2007

    Report

    Report Number
    1525965-2007-00045
    Event Type
    Malfunction
    Date Received
    December 21, 2007
    Date of Event
    December 12, 2007
    Report Date
    December 13, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON MAY 25, 2007, PHILIPS MEDICAL SYSTEMS TOOK ACTION TO ADVISE THE INSTALLED BASE OF THIS MATTER THROUGH A PRODUCT SAFETY NOTIFICATION AND PHILIPS MEDICAL SYSTEMS WILL UPDATE THE CUSTOMER'S SYSTEMS TO MITIGATE THIS ISSUE. THIS EVENT IS SIMILAR TO MDR REPORT 1525965-2007-00006 AND A DECISION WAS REACHED TO FILE AN MDR ON THIS EVENT. THIS ISSUE IS ASSOCIATED WITH CUSTOMER COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTIFACT VISUALIZED AS A SMALL PATTERN OF FOUR LOW CONTRAST DOTS IS PRESENT IN THE BRAIN SCAN. THE PATIENT WAS MISDIAGNOSED WITH A BRAIN BLEED BECAUSE OF THIS ARTIFACT. AFTER FURTHER EVALUATION, THE IMAGE WAS DETERMINED TO BE NON DIAGNOSTIC. NO ADVERSE CONSEQUENCES WERE REPORTED. ORIGINALLY THE NIGHT READING SERVICE READ PATIENT TO HAVE A BLEED. PATIENT WAS PUT UNDER OBSERVATION AND LATER DIAGNOSIS CORRECTION WAS MADE TO NO BLEED. NO SURGICAL TEAM READINESS OR PREPARATION WAS MADE. RADIOLOGISTS FEEL THE ARTIFACT COULD BE MISTAKEN FOR PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE 40 SLICE CT SCANNER COMPUTED TOMOGRAPHY SCANNER JAK PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO