BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADSUITE

    MDR report key: 2840096 · Received June 20, 2012

    Report

    Report Number
    2183926-2012-00001
    Event Type
    Malfunction
    Date Received
    June 20, 2012
    Date of Event
    April 23, 2012
    Report Date
    May 1, 2012
    Manufacturer
    MERGE HEALTHCARE INC
    Product Code
    LLZ
    PMA / PMN Number
    K053281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS CLEARED FOR USE WITH SUV CALCULATION BY FDA IN 12/2005. THIS ISSUE HAS EXISTED SINCE THE INTRODUCTION OF THE CALCULATION. THIS HAS NEVER BEEN REPORTED FROM THE FIELD (NO RELATED COMPLAINTS). THIS ISSUE WAS DISCOVERED DURING INTERNAL TESTING IN A DEVELOPMENT CYCLE. THERE ARE FOUR PT SIZE FACTORS THAT MAY BE USED TO CALCULATE SUV AND IN EACH CASE, EXCEPT FOR BSA, THE CALCULATION IS CORRECT. THIS ISSUE IS PLANNED TO BE CORRECTED IN TWO SEPARATE RELEASES CURRENTLY IN DEVELOPMENT (VERSIONS 5.36 AND 8.30.6). A PRODUCT BULLETIN WILL ALSO BE DISTRIBUTED TO ALL CURRENT CUSTOMERS TO MAKE THEM AWARE OF THE ISSUE.

    Description of Event or Problem · 1

    DURING INTERNAL DEVELOPMENT AND TESTING, IT WAS FOUND THAT THE VALUE FOR THE SUVBSA MEASUREMENTS IN RADSUITE IS TOO HIGH BY A FACTOR OF 10. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADSUITE PACS, IMAGE PROCESSING DEVICE, PRODUCT CODE: LLZ LLZ MERGE HEALTHCARE INC AFFECTS VERSION 5.30.0 AND LATER

    Patients

    Seq Age Sex Outcome Treatment
    1