BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPNO-FLO

    MDR report key: 226880 · Received June 7, 1999

    Report

    Report Number
    1645970-1999-00001
    Event Type
    Malfunction
    Date Received
    June 7, 1999
    Date of Event
    May 25, 1999
    Report Date
    June 4, 1999
    Manufacturer
    KIRK SPECIALTY SYSTEMS
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 5/25/1999 (APPROX @ 7:00 AM), RN WAS PRESENT IN THE ROOM WHILE LVN WAS "BAGGING". DURING THE RESUSCITATION EFFORTS, THEY BELIEVED UNIT TO HAVE A LEAK. IT WAS DISCARDED FOR ANOTHER AND RESUSCITATION EFFORTS CONTINUED. THEY BELIEVED THIS UNIT LEAKED LIKE THE FIRST, DISCARDED IT AND WENT TO A THIRD UNIT. RESUSCITATION EFFORTS WERE SUCCESSFUL WITHOUT FURTHER INCIDENT. THEY PLACED THE PT ON A VENTILATOR. BAGGING MEANS RESUSCITATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPNO-FLO PULMONARY MANUAL RESUSCITATOR BTM KIRK SPECIALTY SYSTEMS K-4346 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO