BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIRK SPECIALTY SYSTEMS CAPNOFLO RESUSCITATOR BAGS

    MDR report key: 430614 · Received November 27, 2002

    Report

    Report Number
    9610849-2002-00006
    Event Type
    Malfunction
    Date Received
    November 27, 2002
    Date of Event
    November 1, 2002
    Report Date
    November 27, 2002
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THE DUCKBILL VALVE ON THE KSS CAPNO FLO RESUSCITATOR BAG WAS MISSING DURING PT VENTILATION. THE CUSTOMER DISCOVERED THAT THE VALVE HAD FALLEN INSIDE THE RESUSCITATOR BAG. CUSTOMER STATES THE CLINICIANS WERE ABLE TO FIND ANOTHER BAG AND VENTILATE THE PT PROPERLY. THERE WAS NO REPORT OF PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIRK SPECIALTY SYSTEMS CAPNOFLO RESUSCITATOR BAGS RESUSCITATOR BAGS BTM NELLCOR PURITAN BENNETT #3-K-4001 2168041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention