BEUDAMED
    FDA Adverse Event Death Summary report: N

    LSP / ALLIED DBMR

    MDR report key: 338334 · Received June 22, 2001

    Report

    Report Number
    MW1022204
    Event Type
    Death
    Date Received
    June 22, 2001
    Report Date
    June 22, 2001
    Manufacturer
    LIFE-ASSIST, INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR CONCERNED ABOUT NEW FEATURE ON MULTIPLE AMBU BAG'S (STATES MORE THAN 1 MFR). A MEDICATION ADMINISTRATION PORT HAS BEEN ADDED TO PREVENT EXPOSURE VERSUS DISCONNECTING BAG FROM ET TUBE. THE MEDICATION PORT IS ON THE OPPOSITE SIDE (OPPOSITE THE OXYGEN SUPPLY TUBE). BOTH PORTS ARE SIMILAR; IF THE PORT IS USED INCORRECTLY A LIFE THREATENING SITUATION ENSUES. RESULTS IN HIGH PRESSURE, IN A CLOSED SYSTEM, LUNGS OVER INFLATE, RUPTURE, PNEUMOTHORAX, DEATH. THERE IS NO WAY TO RELEASE PRESSURE, NO WAY FOR EXHALATION. RPTR AWARE OF TWO DEATHS, ONE PT ALREADY DEAD WHEN STARTED CARE, OTHER PT DIED WHEN USED THE DEVICE. RPTR NOTIFIED THE DISTRIBUTOR AND THE MFR (LEFT MESSAGE ON ANSWERING MACHINE FOR MFR). RPTR TOLD BY USER FACILITY THAT THEY WOULD HANDLE REPORTING THROUGH THEIR INTERNAL SYSTEM. RPTR ALSO NOTES THAT THE PACKAGED INSTRUCTIONS, THE INTERNET (POSTED) INCORRECTLY DEMONSTRATED HOW TO USE THE MEDICATION PORT. RPTR STATES THAT OBSERVED THE DISTRIBUTOR REMOVE THE ON-LINE (INTERNET) USER INSTRUCTIONS/PICTURE. RPTR BELIEVES THIS IS AN EMERGENCY SITUATION REQUIRING IMMEDIATE ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28505 LSP / ALLIED DBMR DISPOSABLE BAG MASK RESUSCITATOR BTM LIFE-ASSIST, INC. OM-5704 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death