BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS

    MDR report key: 2172165 · Received July 14, 2011

    Report

    Report Number
    MW5021420
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 14, 2011
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING DIALYSIS TREATMENT, SMOKE NOTED TO BE COMING FROM THE BACK OF THE MACHINE. BURNT WIRES FOUND AT BACK OF MACHINE UPON INSPECTION BY BIOENGINEERING. MACHINE TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS MACHINE KDI 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR