BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEONARDO

    MDR report key: 512499 · Received February 24, 2004

    Report

    Report Number
    512499
    Event Type
    Other
    Date Received
    February 24, 2004
    Date of Event
    December 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC., A DIV OF EM-PCS
    Product Code
    LMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN WAS REVEIWING CASES ON THE LEONARDO CT [COMPUTERIZED TOMOGRAPHY] WORKSTATION, REVIEWING IMAGES OF "PATEINT" AND NOTICED THAT APPARENTLY "PATIEN" B" 'S CT IMAGES HAD BEEN DOWNLOADED TO PATIENT A'S FOLDER AND THOSE IMAGES WERE INCORRECTLY LABELED WITH PATIENT A'S NAME AND ID NUMBER. PATIENT A AND PATIENT B IDENTIFIERS USED FOR CLARITY IN EXPLAINING THE SITUATION. THERE WERE MULTIPLE IMAGES DOWNLOADED TO THE WRONG FOLDER AND INCORRECTLY LABELED. ONLY THE FACT THAT THE TWO PATIENTS WERE QUITE DIFFERENT IN SIZE MADE THE SITUATION IMMEDIATELY OBVIOUS TO THE RADIOLOGIST. THIS OCCURRENCE HAS BEEN REPORTED TO THE MFR, WHO IS IN THE PROCESS OF INVESTIGATING THE CAUSE. CO DOES NOT BELIEVE ANY STUDIES PRIOR TO THIS ONE HAVE BEEN MIS-LABELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEONARDO RADIOLOGY IMAGING WORKSTATION LMD SIEMENS MEDICAL SOLUTIONS USA, INC., A DIV OF EM-PCS LEONARDO *
    2 SOMATOM VOLUME ZOOM CT CT SCANNER LMD SIEMENS MEDICAL SOLUTIONS USA, INC. VOLUME ZOOM *
    3 SOMATOM VOLUME ZOOM CT CT SCANNER LMD SIEMENS MEDICAL SYSTEMS VOLUME ZOOM *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other THE SIEMENS SOMATOM VOLUME ZOOM CT UNIT WAS USED| FOR THE STUDY AND DOWNLOADED THE IMAGES TO THE| WORKSTATION.