BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA XLT

    MDR report key: 883106 · Received July 18, 2007

    Report

    Report Number
    1220063-2007-00015
    Event Type
    Malfunction
    Date Received
    July 18, 2007
    Date of Event
    June 15, 2007
    Report Date
    July 16, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC HAS RECEIVED INFORMATION THAT ONE OF OUR PATIENT MONITORING DEVICES SHUT DOWN AND HAD TO BE MANUALLY RESTARTED WHILE CONNECTED TO A PATIENT. IT WAS ALSO INDICATED THAT THE DEVICE DID NOT ALARM DURING THIS TIME. 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. 7875938E553U NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR