BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA XLT

    MDR report key: 947426 · Received November 7, 2007

    Report

    Report Number
    1220063-2007-00033
    Event Type
    Malfunction
    Date Received
    November 7, 2007
    Date of Event
    October 9, 2007
    Report Date
    November 7, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFO FROM A CUSTOMER THAT DURING AN OPERATING ROOM PROCEDURE, OUR KAPPA XLT PT MONITOR LOST THE IBP WAVEFORM DISPLAY AND THAT AN INDEPENDENT SURGICAL DISPLAY MONITOR THAT WAS CONNECTED, EXHIBITED WAVEFORMS THAT WERE NOT THAT OF A PT BUT EXHIBITED SIMULATED WAVEFORMS. THE CUSTOMER RE-STARTED THE KAPPA XLT AND IT FUNCTIONED NORMALLY. AT THE TIME OF THE EVENT, NO CHANGES WERE MADE BY THE USER ON THE KAPPA XLT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA XLT PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. MS14618 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR