BEUDAMED
    FDA Adverse Event Summary report: N

    TZ MEDICAL BOOKER BOX

    MDR report key: 2334818 · Received November 8, 2011

    Report

    Report Number
    MW5023024
    Date Received
    November 8, 2011
    Date of Event
    October 20, 2011
    Manufacturer
    TZ MEDICAL, INC.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN THE CASE OF THIS PROCEDURE ON PT, THE BOOKER BOX HAD A PRE-EXISTING UNK, INTERNAL "MAKE OR BREAK CONNECTION FAILURE" WHICH BASICALLY PREVENTED THE EXTERNAL DEFIBRILLATOR FROM BEING ABLE TO DELIVER AN EXTERNAL (OR INTERNAL SHOCK) TO THE PT. DURING THE PROCEDURE ON PT (B)(6), THE FIRST SHOCK FROM THE IMPLANTED ICD FAILED TO TERMINATE HIS VENTRICULAR FIBRILLATION AND SO, PER OUR PROTOCOL, THE EXTERNAL DEFIBRILLATOR WAS CHARGED UP TO 200 JOULES IN PREPARATION OF SHOCKING THE PT WITH THE EXTERNAL DEFIBRILLATOR. HOWEVER, WHEN THE NURSE ATTEMPTED TO DELIVER THE SHOCK TO THE PT, AN ERROR MESSAGE CAME UP ON THE DEFIBRILLATOR INDICATING THAT THE SHOCK COULD NOT BE DELIVERED BECAUSE THE DEFIBRILLATOR COULD NOT "SEE" THE PT - THE ERROR MESSAGE INDICATED THAT THE EXTERNAL DEFIBRILLATION PADS WERE NOT ATTACHED TO THE PT, WHEN IN FACT THEY WERE. BELIEVING THAT THE BOOKER BOX WAS THE PROBLEM, NURSING PERSONNEL QUICKLY REMOVED THE BOOKER BOX DEVICE FROM THE CIRCUIT AND THE EXTERNAL DEFIBRILLATOR WAS DIRECTLY HOOKED UP TO THE PT (W/O THE INTERPOSED BOOKER BOX). ONCE THIS WAS DONE, THE ERROR MESSAGE ON THE EXTERNAL DEFIBRILLATOR AGAIN BECAME FULLY FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TZ MEDICAL BOOKER BOX BOOKER BOX LDD TZ MEDICAL, INC.
    2 VI-MPC CABLE DEFIBRILLATOR CABLE/PATIENT ELECTRODE CABLE DSA TZ MEDICAL, INC.
    3 VI-MPC CABLE DEFIBRILLATOR CABLE/PATIENT ELECTRODE CABLE DSA TZ MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention