BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9616240-2006-00348

    MDR report key: 728515 · Received June 20, 2006

    Report

    Report Number
    9616240-2006-00348
    Event Type
    Malfunction
    Date Received
    June 20, 2006
    Product Code
    FDI
    PMA / PMN Number
    k010805
    Removal / Correction Number
    Z-1545-05
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS ONLY A SLIGHT DISCREPANCY IN PT FLUID REMOVAL. THERE WAS NO PT INJURY AND NO REQUEST TO HAVE THE MACHINE CHECKED BY GAMBRO. NO MACHINE SERIAL NUMBER PROVIDED. MORE INFO WAS ASKED REGARDING THE REPORTED INCIDENT. TO DATE, NO ADDITIONAL INFO WAS PROVIDED. 510(K)# IS K010805

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1