BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DISPOSABLE RESUSCITATOR

    MDR report key: 17006 · Received October 20, 1994

    Report

    Report Number
    MW1003741
    Event Type
    Malfunction
    Date Received
    October 20, 1994
    Date of Event
    October 15, 1994
    Report Date
    October 17, 1994
    Manufacturer
    AMBU, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    UNIT HAS ATTACHED SWIVEL CONNECTOR. SWIVEL IS LEAKING WHEN BAG IS COMPRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DISPOSABLE RESUSCITATOR ADULT DISPOSABLE RESUSCITATOR BTM AMBU, INC. 94266, 20144180

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other