BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9616026-2006-00240

    MDR report key: 728450 · Received June 21, 2006

    Report

    Report Number
    9616026-2006-00240
    Event Type
    Malfunction
    Date Received
    June 21, 2006
    Product Code
    FII
    PMA / PMN Number
    k041005
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INJURY WAS REPORTED. A GAMBRO FIELD REP INVESTIGATED THE MACHINE. RAN SIMULATED TREATMENT WITH VALUE SET BY THE OPERATOR, COULD NOT REPRODUCE THE REPORTED CONDITION. 510(K)# IS K041005

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FII

    Patients

    Seq Age Sex Outcome Treatment
    1