BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21330468 · Received February 7, 2025

    Report

    Report Number
    2016493-2025-03439
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 9, 2025
    Report Date
    February 7, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE APPLICATION FAILED TO LAUNCH. A TECHNICAL SUPPORT SPECIALIST REFERRED TO KNOWLEDGE ARTICLE 000011541 "MED APPLICATION NOT LAUNCHING AUTOMATICALLY, STATION AT BLUE SCREEN" & 000011447 "HOW TO MANUALLY INSTALL RSS AGENTS & RSS COMPONENT MANAGER". A TECHNICAL SUPPORT SPECIALIST INSTALLED VERSION 4.12 OF THE REMOTE SUPPORT SERVICES AND ADJUSTED THE PATH TO INCORPORATE "(X86)" FOR THE DEPENDENCIES.XML FILE. AFTER REBOOTING THE STATION, THE MED APPLICATION WAS SUCCESSFULLY LAUNCHED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOTED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE PYXIS MEDSTATION ES SYSTEM WAS UNRESPONSIVE AND STUCK ON THE SCREEN. THE CUSTOMER REPORTED THAT THE MALFUNCTION OCCURRED WHEN USER TRYING TO ISSUE THE MEDICATION TO PATIENT AND THERE WAS NO DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299134 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown