BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NARKOMED

    MDR report key: 5067483 · Received September 10, 2015

    Report

    Report Number
    2510954-2015-00004
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 12, 2015
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A DRÄGER SERVICE TECHNICIAN. PART OF THE EVALUATION INVOLVED REVIEWING THE LOG FILES WHICH CONTAINED AN ENTRY INDICATING A POWER SUPPLY SHUT DOWN. THE TECHNICIAN REPLACED THE POWER SUPPLY. THE POWER SUPPLY WAS EVALUATED BY D...

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE DEVICE DISPLAY WENT BLANK AND THE MACHINE SHUT DOWN. THE MACHINE WAS SWAPPED OUT AND THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600081 NARKOMED ANESTHESIA MACHINE CBK DRAEGER MEDICAL, INC. 6400

    Patients

    Seq Age Sex Outcome Treatment
    1