BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU FILTER

    MDR report key: 168478 · Received May 19, 1998

    Report

    Report Number
    MW1013855
    Event Type
    Malfunction
    Date Received
    May 19, 1998
    Report Date
    April 23, 1998
    Manufacturer
    KENTEC MEDICAL, INC.
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON CHANGING FILTERS ON AN AIRSHIELDS MODEL 400 INFANT INCUBATOR, IT WAS NOTICED THAT THE NEW FILTER WAS THICKER THAN THE ONE REMOVED. THE OXYGEN PERCENTAGE INSIDE THE INCUBATOR WAS CHECKED AND FOUND TO BE LOWER THAN SPECIFIED BY THE MFR. UPON INSTALLING THE OLD FILTER ONCE AGAIN (AIR SHIELDS FILTER) THE OXYGEN PERCENTAGE INCREASED TO WELL INTO THE SPECIFIED LIMITS. (EXAMPLE: AT 6 LITERS PER MINUTE OXYGEN, THE OXYGEN LEVEL SHOULD BE BETWEEN 33 -41%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU FILTER DISPOSABLE INCUBATOR FILTER FMZ KENTEC MEDICAL, INC. * 052797E7

    Patients

    Seq Age Sex Outcome Treatment
    1 *