BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX

    MDR report key: 3113343 · Received August 3, 2006

    Report

    Report Number
    2087532-2006-00171
    Event Type
    Malfunction
    Date Received
    August 3, 2006
    Report Date
    June 5, 2006
    Manufacturer
    GAMBRO DASCO
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MACHINE PULLED TOO MUCH FLUID DURING TREATMENT. PLEASE REFER MFR # 9616240-2006-00358.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX HEMODIALYSIS EQUIPMENT KDI GAMBRO DASCO PHOENIX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other