BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU

    MDR report key: 219162 · Received April 9, 1999

    Report

    Report Number
    MW1016138
    Event Type
    Malfunction
    Date Received
    April 9, 1999
    Date of Event
    March 20, 1999
    Report Date
    April 1, 1999
    Manufacturer
    AMBU, INC.
    Product Code
    BYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PEEP VALVE WOULD NOT STAY AT DESIRED PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU POSITIVE END EXPIRATORY PRESSURE VALVE BYE AMBU, INC. 900-000-013 98299

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other