BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA XLT

    MDR report key: 4092753 · Received September 9, 2014

    Report

    Report Number
    1220063-2014-00028
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Report Date
    August 11, 2014
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON SEVERAL OCCASIONS, SINCE SEVERAL MONTHS, SOME BLACKOUTS OF THE MONITORING SCREEN ON THE KAPPA XLT WERE SEEN, IN USE IN THE OPERATING ROOM. THE SCREEN SUDDENLY GOES BLACK, TOTALLY RANDOM, WITH OR WITHOUT ALARM. IT WAS THOUGHT THAT IT COULD BE A BREAKDOWN, BUT AFTER SEVERAL TECHNICAL INTERVENTIONS BY DRAEGER TECHNICAL SERVICE, IT WAS FOUND THAT THE POWER SUPPLY WAS NOT INVOLVED, BUT THAT IT WAS A SOFTWARE PROBLEM. SIGNIFICANT DIFFICULTIES WERE ALSO FOUND REGARDING THE MEASUREMENT OF PNI WITH HYPOTENSIVE AND HYPERTENSIVE PATIENTS. KAPPA XLT CAN TAKE OVER A MINUTE TO TAKE A MEASURE OF PNI. THERE WAS NO PATIENT INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551803 KAPPA XLT PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1