BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIS MOBILE

    MDR report key: 19270872 · Received May 8, 2024

    Report

    Report Number
    2024168-2024-05646
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 15, 2024
    Report Date
    June 17, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NQQ
    PMA / PMN Number
    K152120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, SYSTEM LOGS WERE PROVIDED. A REVIEW OF THE CATSWEB (CORRECTIVE ACTION TRACKING SYSTEM FOR THE WEB) DATABASE FOR THE ULTREON WAS PERFORMED AND REVEALED NO RELATED COMPLAINT ASSESSMENT EXCEPTIONS. BASED ON THESE REVIEWS, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE. THE SYSTEM EVENT LOGS WERE CHECKED FOR ANY ANOMALOUS BEHAVIOR LIKE UNAUTHORIZED EXECUTION OF SCRIPTS/APPLICATIONS/FILES, MULTIPLE UNSUCCESSFUL LOGIN ATTEMPTS, ABNORMAL USER ACTIVITIES LIKE MULTIPLE USER CREATION OR CHANGE OF USER GROUPS, AND UNAUTHORIZED SYSTEM CONFIGURATION CHANGES. NONE OF THE ABOVE-MENTIONED ANOMALOUS BEHAVIOR WAS OBSERVED ON THE SYSTEM. THE 4403 WARNING WAS TRIGGERED BY A TEMPORARY, UNSIGNED TEST POWERSHELL SCRIPT, GENERATED BY WINDOWS MAINTENANCE TASKS TO TEST AGAINST APPLOCKER. IF THE SCRIPT EXECUTES THEN IT IS ASSUMED THAT APPLOCKER IS DISABLED. IF THE SCRIPT DOES NOT EXECUTE THEN POWERSHELL ASSUMES APPLOCKER IS ENABLED. THE TEST SCRIPT DOES NOT CONTAIN ANY EXECUTABLE COMPONENTS. THE COMBINATION OF NO PRESENCE OF ANOMALOUS OR MALICIOUS BEHAVIOR AND TRIGGER BEING OS GENERATED TEST SCRIPT, THIS COMPLIANT IS DETERMINED TO BE A FALSE POSITIVE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT, CYBER LOG REVIEW DETERMINED THE POTENTIAL CYBER ISSUE TO BE A FALSE POSITIVE AND NO NEW UNACCEPTABLE OR ACCEPTABLE WAS IDENTIFIED. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION OF THE OPTIS MOBILE SYSTEM, DICOM ERRORS 4403, 1923, AND 2104 WERE DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT. A POTENTIAL CYBER SECURITY ISSUE OCCURRED. FIELD SERVICE WAS PERFORMED AND A STORAGE TAB NEXT TO DICOM WAS ESTABLISHED TO BE ABLE TO CORRECTLY EXPORT TO DICOM. THE SYSTEM IS READY FOR USE. NO ADDITIONAL INFORMATION WAS PROVIDED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772345 OPTIS MOBILE ULTRASONIC PULSED ECHO IMAGING SYSTEM NQQ ABBOTT VASCULAR 6739805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown