BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA XLT

    MDR report key: 967191 · Received December 17, 2007

    Report

    Report Number
    1220063-2007-00041
    Event Type
    Injury
    Date Received
    December 17, 2007
    Date of Event
    November 6, 2007
    Report Date
    December 10, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REQUESTED THE CITED SPO2 SENSOR INVOLVED IN THE REPORTED EVENT TO BE RETURNED FOR EVALUATION. THE COMPLAINT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION FROM A CUSTOMER THAT WHILE IN USE ON A PATIENT, OUR KAPPA XLT MONITOR EXPERIENCED A LOSS OF THE SPO2 SIGNAL FOR APPROXIMATELY 15 MINUTES DURING A PROCEDURE IN THE OPERATING ROOM. VISUAL AND AUDIBLE ALARMS WERE PRESENT DURING THE EVENT WHEN THE PATIENT CODED AND WAS REVIVED. THE PATIENT WAS COMATOSE AFTER THE OCCURRENCE. THE KAPPA XLT MONITOR CONTINUED TO DISPLAY THE ECG WAVEFORM AND PARAMETERS DURING THIS TIME BUT SPO2 MEASUREMENTS WERE NOT BEING DISPLAYED. THE STAFF TRIED TO REESTABLISH SPO2 MONITORING FOR APPROXIMATELY 15 MINUTES AND THEN CHANGED THE SPO2 SENSOR AND WAS ABLE TO REESTABLISH MONITORING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Life Threatening| R