BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELEPACS

    MDR report key: 2182430 · Received July 11, 2011

    Report

    Report Number
    9615916-2011-00002
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Report Date
    July 7, 2011
    Manufacturer
    INTELERAD MEDICAL SYSTEMS
    Product Code
    LLZ
    PMA / PMN Number
    K083520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN NO INDICATION FROM THE REPORTING HEALTH FACILITY THAT ANY PATIENT WAS AFFECTED ADVERSELY BY THIS MALFUNCTION. ONE OTHER FACILITY HAD THE SOFTWARE AND WERE CONFIGURED TO OPERATE THE DEFECTIVE SOFTWARE. HOWEVER, THE MALFUNCTION DID NOT OCCUR AT THIS SITE. BOTH SITES HAVE SINCE BEEN UPDATED WITH CORRECTED SOFTWARE. AS A PRECAUTION, WE WILL BE UPDATING ANOTHER 21 SITES THAT HAVE, BUT ARE NOT CONFIGURED TO OPERATE THE DEFECTIVE SOFTWARE.

    Description of Event or Problem · 1

    CONVERSION OF REPORTS FROM HTML TO RICH TEXT FORMAT (RTF) WILL, ON RARE OCCASIONS, DELETE LINES FROM THE RTF REPORT THAT WERE IN THE ORIGINAL HTML REPORT. THE PROBLEM ONLY OCCURS FOR CERTAIN TYPES OF HTML FORMATTING, AND WHEN INTELEPACS HAS BEEN CONFIGURED TO RETURN RTF REPORTS BACK TO THE RIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELEPACS LLZ INTELERAD MEDICAL SYSTEMS 411-R22,R23,421-R16

    Patients

    Seq Age Sex Outcome Treatment
    1