BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA XLT

    MDR report key: 928012 · Received October 11, 2007

    Report

    Report Number
    1220063-2007-00029
    Event Type
    Malfunction
    Date Received
    October 11, 2007
    Date of Event
    September 7, 2007
    Report Date
    October 11, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION FROM A CUSTOMER THAT DURING AN OPERATING ROOM PROCEDURE OUR KAPPA XLT PATIENT MONITOR DISPLAY WENT "BLACK" AND NO PARAMETERS WERE DISPLAYED WHILE THEY WERE USING AN ELECTRICAL SURGICAL DEVICE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA XLT PATIENT MONITOR DRT DRAEGER MEDICAL SYSTEMS, INC. MS14619 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR