BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUDOSE

    MDR report key: 4945121 · Received July 27, 2015

    Report

    Report Number
    4945121
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    July 26, 2015
    Report Date
    July 27, 2015
    Manufacturer
    AESYNT INCORPORATED
    Product Code
    NXB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ACUDOSE MACHINE CONTINUES TO MALFUNCTION. NARCOTIC POCKETS ARE STILL AVAILABLE (GREEN LIGHT) TO BE OPENED WITHOUT ASKING FOR THE MEDICATION. PHARMACY PERSONNEL ARE AWARE AND DRAWER IS TO BE REPLACED. NO ACCESS TO DRAWER ONE FOR THE STAFF TO ACCESS MEDICATION, THUS THE NURSES ARE REQUIRED TO WALK TO A DIFFERENT UNIT FOR MEDICATION INCREASING THE TIME INTERVAL BETWEEN THE TIME PATIENT CALLS FOR MEDICATION AND ADMINISTRATION IS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486859 ACUDOSE MEDICATION DISPENSING SYSTEM NXB AESYNT INCORPORATED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *