BEUDAMED
    FDA Adverse Event Other Summary report: N

    9616240-2006-00332

    MDR report key: 727600 · Received June 1, 2006

    Report

    Report Number
    9616240-2006-00332
    Event Type
    Other
    Date Received
    June 1, 2006
    Product Code
    FII
    PMA / PMN Number
    k001156
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INJURY REPORTED. CLINICAL INVESTIGATION IS ONGOING. A GAMBRO TECHNICAL SERVICES (GTS) FIELD REP INSPECTED THE MACHINE. HE PERFORMED A SIMULATED RUN AND MACHINE WORKED PROPERLY. HE WAS NOT ABLE TO DUPLICATE THE PROBLEM. 510(K)# IS K001156

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1