BEUDAMED
    FDA Adverse Event Summary report: N

    INTELLISPACE PORTAL

    MDR report key: 3716700 · Received March 4, 2014

    Report

    Report Number
    1525965-2014-00040
    Date Received
    March 4, 2014
    Report Date
    February 5, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A F/U MDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4)

    Description of Event or Problem · 1

    PHILIPS REC'D FEEDBACK FROM A CUSTOMER, REPORTING THAT THERE ARE DIFFERENCES IN THE QUANTITATIVE PERFUSION SPECT (QPS) IN AUTOQUANT RESULTS BETWEEN THE INTELLISPACE PORTAL (ISP) AND EXTENDED BRILLIANCE WORKSPACE (EBW). IT WAS FOUND THAT THE INTELLISPACE PORTAL RECONSTRUCTION SOMETIMES PRODUCES INACCURATE RESULTS WHEN IT USES THE ASTONISH ALGORITHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129171 INTELLISPACE PORTAL LLZ PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 881001

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening