BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELEPACS

    MDR report key: 9751805 · Received February 25, 2020

    Report

    Report Number
    9615916-2020-00002
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Date of Event
    February 7, 2020
    Report Date
    February 20, 2020
    Manufacturer
    INTELERAD MEDICAL SYSTEMS
    Product Code
    LLZ
    UDI-DI
    B228INTELEPACS0
    PMA / PMN Number
    K150707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    N.A.

    Description of Event or Problem · 1

    A USER REPORTED THAT APPROXIMATELY 1000 STUDIES WERE LOST FROM THE PACS STORAGE AND A REFERRING PHYSICIAN WAS UNABLE TO VIEW IMAGES. RADIOLOGIST REPORTS FOR THESE DELETED STUDIES REMAINED AVAILABLE. PRELIMINARY ANALYSIS DETERMINED THE PROBLEM IS DUE TO A CONFIGURATION KEY THAT WAS ACTIVATED IN COMBINATION WITH A SOFTWARE BUG. WHEN THE FEATURE FORCEGLOBALSTUDYDELETION IS ENABLED, ANY SERIES DELETIONS THAT OCCUR ON A SERVER ARE AUTOMATICALLY ELEVATED TO A SYSTEM-LEVEL STUDY DELETION. THIS SYSTEM-LEVEL DELETION BYPASSES EXISTING MITIGATION POLICIES (I.E., ARCHIVE POLICIES) ON OTHER SERVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212147 INTELEPACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM LLZ INTELERAD MEDICAL SYSTEMS INTELEPACS 4-9-1 AND UP B228INTELEPACS0

    Patients

    Seq Age Sex Outcome Treatment
    1