BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS BIOGRAPH 16 SLICE

    MDR report key: 1942596 · Received December 20, 2010

    Report

    Report Number
    1942596
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    March 16, 2010
    Report Date
    December 20, 2010
    Manufacturer
    SIEMENS
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH A HISTORY OF MELANOMA CAME IN FOR A POSITRON EMISSION TOMOGRAPHY (PET) SCAN. SOFTWARE IS DESIGNED IN A WAY THAT WHEN YOU DO A WHOLE BODY SCAN YOU WOULD HAVE TO MANUALLY RECONSTRUCT THE DATA. UNFORTUNATELY, THE TECHNICIAN DID NOT DO QUALITY ASSURANCE CHECK ON THE FILM AND A HOTSPOT OF THE PATIENT'S KNEE WAS MISSED AS FILM FROM THE WAIST DOWN WAS NOT RECONSTRUCTED PRIOR TO THE DATA BEING SENT TO THE RADIOLOGIST FOR READING. NUCLEAR MEDICINE DIRECTOR SPOKE TO SIEMENS AND WAS TOLD THERE IS NEW SOFTWARE OUT THERE; HOWEVER, THEY DO NOT SUPPORT IT. WE ARE STILL CURRENTLY INVESTIGATING THIS EVENT. WE WERE NOT NOTIFIED OF THIS UNTIL THREE MONTHS AGO AND I WAS WAITING TO GET ADDITIONAL INFORMATION PRIOR TO SUBMISSION OF THIS REPORT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================SOFTWARE IS DESIGNED IN A WAY THAT WHEN DOING A FULL BODY SCAN, THE TECHNICIAN HAS TO MANUALLY RECONSTRUCT DATA TO ENSURE COMPLETION OF THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS BIOGRAPH 16 SLICE PET CT SCANNER JAK SIEMENS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR