BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUDOSE RX

    MDR report key: 3994212 · Received July 24, 2014

    Report

    Report Number
    3994212
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    AESYNT INCORPORATED
    Product Code
    BRY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE ANESTHESIA SUPERVISOR WENT TO RE-STOCK MEDICATIONS INTO THE CART. THE MACHINE WAS FROZEN AND NEITHER THE TOUCH SCREEN NOR THE KEYBOARD WOULD RESPOND. THE OPERATOR WAS UNABLE TO LOG IN. THE OPERATOR TRIED RE-BOOTING THE MACHINE WITH THE BLACK RESET BUTTON ON THE LEFT. THE MACHINE ONLY RE-BOOTED AFTER A FULL RESET WITH THE KEY THE 2 RESET SWITCHES ON THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433837 ACUDOSE RX CABINET, TABLE AND TRAY, ANESTHESIA BRY AESYNT INCORPORATED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *