BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUDOSE-RX

    MDR report key: 3994220 · Received July 24, 2014

    Report

    Report Number
    3994220
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 23, 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 PHYSICIAN WAS PULLING MEDICATIONS FOR HIS PATIENT. HE PULLED FENTANYL, THEN WHILE PULLING MIDAZOLAM THE MACHINE POPPED THE "UNRECOVERABLE ERROR" MESSAGE THEN REBOOTED. PATIENT WAS ON THE TABLE AND IT WAS PRIOR TO ANESTHESIA BEING ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435320 ACUDOSE-RX CABINET, TABLE AND TRAY, ANESTHESIA BRY AESYNT INCORPORATED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *