BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUDOSE

    MDR report key: 4143254 · Received September 19, 2014

    Report

    Report Number
    4143254
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 19, 2014
    Manufacturer
    AESYNT CORPORATION
    Product Code
    BRY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) WAS TRYING TO LOG INTO ANESTHESIA ACUDOSE. WHEN SHE WENT TO USE THE MACHINE THE SYSTEM WAS FROZEN. NEITHER THE KEYBOARD NOR THE TOUCHSCREEN WOULD RESPOND. WE REBOOTED THE MACHINE WITH THE BUTTON ON THE LEFT SIDE. IT TOOK 3-4 MINUTES TO REBOOT. ONCE THE SYSTEM CAME BACK UP EVERYTHING WAS WORKING AT ITS NORMAL PACE. AESYNT WAS CALLED. THEY SAID THEY WILL REACH BACK TO US WITHIN 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583165 ACUDOSE ANESTHESIA CART BRY AESYNT CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *