BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XHIBIT CENTRAL STATION

    MDR report key: 23855854 · Received December 19, 2025

    Report

    Report Number
    3010157426-2025-00241
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    December 9, 2025
    Report Date
    December 19, 2025
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    UDI-DI
    10841522127069
    PMA / PMN Number
    K122146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT THEIR XHIBIT CENTRAL STATION (XCS) WOULD OCCASIONALLY BECOME FROZEN. IT WAS STATED THAT THE CUSTOMER WOULD PERFORM A HARD SHUT DOWN AND THE DEVICE WOULD FUNCTION NORMALLY AGAIN FOR A PERIOD OF TIME BEFORE BECOMING FROZEN AGAIN. THE ISSUE HAS BECOME MORE FREQUENT OVER TIME. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THE ISSUES WITH THE XCS. A PRODUCT SUPPORT SPECIALIST (PSS) REVIEWED THE XCS LOGS AND FOUND THAT THE DEVICE WAS FREEZING DUE TO THE COMPUTER RUNNING OUT OF MEMORY. THE PSS FURTHER IDENTIFIED THE MEMORY ISSUES INDICATED A PROBLEM WITH THE MICROSOFT WINDOWS EXTENSIBLE STORAGE ENGINE (ESE), WHICH CAN CAUSE DATABASE FILE'S INTEGRITY OR ACCESS, LEADING TO POTENTIAL APPLICATION MALFUNCTIONS. THE PSS ADVISED THE CUSTOMER'S FIELD SERVICE ENGINEER (FSE) TO PERFORM A CLEAN INSTALLATION OF THE XCS SOFTWARE TO PREVENT FURTHER ISSUES WITH THE XHIBIT SOFTWARE. AFTER THE FSE PERFORMED A CLEAN INSTALL OF THE SOFTWARE ON THE XCS, THE DEVICE PASSED FUNCTIONAL TESTING AND WAS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346030 XHIBIT CENTRAL STATION CENTRAL STATION REMOTE MONITOR MHX SPACELABS HEALTHCARE 96102 10841522127069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown