BEUDAMED
    FDA Adverse Event Summary report: N

    EXTENDED BRILLIANCE WORKSPACE NM

    MDR report key: 3142883 · Received May 30, 2013

    Report

    Report Number
    1525965-2013-00144
    Date Received
    May 30, 2013
    Report Date
    May 2, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    LLZ
    PMA / PMN Number
    K111336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT WHERE THE CUSTOMER HAD PROCESSED A PT STUDY USING THE EMORY CARDIAC TOOLBOX (ECT) 3.2 APPLICATION ON THEIR EXTENDED BRILLIANCE WORKSPACE (EBW) NM PROCESSING STATION TO DO A VIABILITY STUDY COMPARING A TC-SESTAMIBI CARDIAC REST TO A FDG-PET STUDIES PERFORMED ON THE SAME PT. THE PT STUDY WAS PROCESSED AND SENT TO THE READING PHYSICIAN WHO READ IT AS BEING ABNORMAL USING THE ECT 3.2 APPLICATION ON THE EBW NM PROCESSING STATION. BASED ON THE GENERATED RESULTS OF THE VIABILITY STUDY PERFORMED USING THE ECT 3.2 APPLICATION, THE PT WAS SCHEDULED TO GO FOR A HEART CATHETERIZATION WHEN THE PT STUDY WAS RE-READ AT THE CUSTOMER SITE. AFTER RE-READING THE PT STUDY, THE READING PHYSICIAN NOTICED IT WAS NOT AN ABNORMAL PT STUDY AND CANCELED THE HEART CATHETERIZATION FOR THE PT AT THE CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238408 EXTENDED BRILLIANCE WORKSPACE NM LLZ PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 882489

    Patients

    Seq Age Sex Outcome Treatment
    1