BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSELECT FLEX AUTOMATED MEDICATION DISPENSING CABINETS

    MDR report key: 16953770 · Received May 17, 2023

    Report

    Report Number
    MW5117646
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    May 11, 2023
    Report Date
    May 15, 2023
    Manufacturer
    ARXIUM INC.
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MEDSELECT FLEX AUTOMATED MED DISPENSING CABINET'S CONNECTION BETWEEN HARDWARE AND SOFTWARE FREQUENTLY MALFUNCTIONS REQUIRING HOSPITAL PHARMACY STAFF TO GO TO LOCATION AND COMPLETE A HARD REBOOT OF THE MACHINE. COMMON ERRORS INCLUDE COMPUTER SCREEN FREEZING, SOFTWARE "DISPENSING" AND REMOVING FROM COUNTS, BUT DRAWERS TO DO NOT OPEN. THIS IS LEADING TO DELAYS IN ACCESSING PATIENT MEDICATIONS IN OUR EDS AND PATIENT UNITS AS WELL AS PROCEDURES DELAY IN OUR ENDOSCOPY SUITES. DATE OF EVENT ABOVE IS ONLY ONE OF MANY EXAMPLES WITH THIS COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650579 MEDSELECT FLEX AUTOMATED MEDICATION DISPENSING CABINETS SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP ARXIUM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other