BEUDAMED
    FDA Adverse Event Other Summary report: N

    F-30

    MDR report key: 409371 · Received July 31, 2002

    Report

    Report Number
    1221261-2002-00068
    Event Type
    Other
    Date Received
    July 31, 2002
    Report Date
    July 31, 2002
    Manufacturer
    LEVEL 1, INC.
    Product Code
    BRZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A HOSP PERFORMED TESTING ON TEH F-30 AND CONCLUDED "THE AIR ELIMINATOR EXAMINED IN THE CO'S STUDY DID NOT RELIABLY ELIMINATE MACROBOLUSES OF AIR AND WAS EASILY OVERWHELMED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F-30 F-30 REPLACEMENT FILTER WITH GAS VENT BRZ LEVEL 1, INC. F-30 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other