BEUDAMED
    FDA Adverse Event Summary report: N

    RESP-BAC

    MDR report key: 14678 · Received July 14, 1994

    Report

    Report Number
    MW1002817
    Date Received
    July 14, 1994
    Date of Event
    July 7, 1994
    Report Date
    July 7, 1994
    Manufacturer
    MEDICOMP, INC.
    Product Code
    CAH
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    FILTER USED IN POSITIVE PRESSURE BREATHING UNITS, WITH FILTER IN-LINE. RPTR WAS UNABLE TO GENERATE AND MAINTAIN DESIRED VENTILATING PRESSURES. UPON REMOVAL OF FILTER, NOTED SEVERAL FILTERS NOT SEALED AT SEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESP-BAC CAH MEDICOMP, INC. 7402

    Patients

    Seq Age Sex Outcome Treatment
    1 *