BEUDAMED
    FDA Adverse Event Summary report: N

    INTELLISPACE PORTAL

    MDR report key: 3738483 · Received March 31, 2014

    Report

    Report Number
    1525965-2014-00063
    Date Received
    March 31, 2014
    Report Date
    March 5, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    LLZ
    PMA / PMN Number
    K060937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A F/U MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4). INITIAL MDR MAILED ON (B)(4) 2014.

    Description of Event or Problem · 1

    PHILIPS REC'D FEEDBACK FROM A CUSTOMER, REPORTING THAT THERE ARE DIFFERENCES IN AUTOQUANT RESULTS BETWEEN THE INTELLISPACE PORTAL (ISP) AND EXTENDED BRILLIANCE WORKSPACE (EBW). ISP5 AUTOQUANT RESULTS DO NOT MATCH THE RESULTS OF THOSE IN EBW (NUCLEAR MEDICINE) AND JETSTREAM WORKSTATION (JSWS), AND ARE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192614 INTELLISPACE PORTAL SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED LLZ PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 881001

    Patients

    Seq Age Sex Outcome Treatment
    1