BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITREA ENTERPRISE SUITE

    MDR report key: 2388776 · Received November 3, 2011

    Report

    Report Number
    2134213-2011-00001
    Event Type
    Malfunction
    Date Received
    November 3, 2011
    Date of Event
    June 14, 2011
    Report Date
    November 1, 2011
    Manufacturer
    VITAL IMAGES, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K061624
    Removal / Correction Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL INVESTIGATION OF THIS ISSUE FOUND THE SUV ERROR WAS DUE TO INVALID DICOM HEADER INFO OF IMAGES PROVIDED BY A PHILIPS HEALTHCARE GEMINI 64 TIME-OF-FLIGHT WHEN USING BQML UNITS. THE INVALID DICOM HEADER ISSUE WAS FORWARDED TO PHILIPS HEALTHCARE. VITAL IMAGES BECAME AWARE ON (B)(4), 2011 THAT THERE WAS AN ISSUE WITH THE VITREA PRODUCT. THE ISSUE WAS FOUND WHILE EVALUATING A POTENTIAL WORKAROUND FOR THE INVALID DICOM HEADER. THE ERROR IS UNIQUE TO THE ACQUISITION WORKFLOW USED TO CREATE THE EXAMPLE IMAGES PROVIDED BY THE CUSTOMER. THE VITREA ERROR WAS NOT DETECTABLE UNTIL THE EFFECT OF THE ORIGINAL IMAGE DICOM ERROR WAS REMOVED.

    Description of Event or Problem · 1

    DR. (B)(6) REPORTED THAT THE VES STANDARD UPTAKE VALUE (SUV) MEASUREMENTS WERE NOT CONSISTENT WITH OTHER POST-PROCESSING SYSTEM WHILE COMPARING SUVS BETWEEN THREE POST-PROCESSING SYSTEMS. DR. (B)(6) FOUND THIS WHILE EXPLORING DIFFERENCES BETWEEN SYSTEMS AND NOT DURING PT CARE. NO INJURIES WERE REPORTED RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITREA ENTERPRISE SUITE PICTURE ARCHIVING AND COMMUNICATIONS SYS LLZ VITAL IMAGES, INC. 1.3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA