BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL MEDICAL

    MDR report key: 1103363 · Received August 7, 2008

    Report

    Report Number
    MW5007925
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    R-SERIES DEFIBRILLATOR WITH ONESTEP CPR A/A ELECTRODES, LOT # 0808, ON CODE CART. PATIENT WENT INTO PULSELESS V-TACH. UNABLE TO DEFIBRILLATE WITH DISPOSABLE ELECTRODES, AS DEFIBRILLATOR READ "DEFIB PAD SHORT." DEFIBRILLATOR MULTI-FUNCTION CABLE CONNECTED TO HARD PADDLES. PATIENT SUCCESSFULLY DEFIBRILLATED AND STABILIZED. THE EQUIPMENT INVOLVED WAS A ZOLL R-SERIES DEFIBRILLATOR TO WHICH WAS CONNECTED A SET OF "ONESTEP CPR A/A" RESUSCITATION ELECTRODES, LOT # 0808. VERBATIM FROM THE INCIDENT REPORT: "PT WITH V TACH ARREST. PT HOOKED UP TO DEFIBRILLATOR ONLY FOR MONITOR TO READ "DEFIB SHORT." UNABLE TO RESOLVE PROBLEMS BY QUICKLY LOOKING AT CONNECTIONS. PADS REMOVED AND GEL PADS APPLIED, AND PT DEFIBRILLATED USING PADDLES. NO PROBLEMS ONCE PADDLES USED. PT DEFIBRILLATED ADEQUATELY AND RHYTHM ESTABLISHED." AS OF THIS MOMENT, WE HAVE SEQUESTERED THE DEFIBRILLATOR. SEQUESTERED THE ELECTRODES AND PACKAGING. IT APPEARS THAT THE ELECTRODES WERE OPENED CORRECTLY AS THE ENDS OF THE "JUMPER WIRE" ARE CLEARLY VISIBLE IN THE PACKAGING. INTERVIEWED THE NURSE WHO WAS OPERATING THE DEFIBRILLATOR DURING THE CODE, WHO VERIFIED THAT THE ELECTRODE PACKAGE WAS OPENED CORRECTLY. DOWNLOAD THE CODE REPORT FROM THE DEFIBRILLATOR. SAVED A VIDEO OF THE ENTIRE CODE, AS THE PATIENT WAS BEING MONITORED VIA A CLOSED CIRCUIT VIDEO SYSTEM. WE WISH TO OPEN AN INVESTIGATION INTO THIS INCIDENT AS I AM UNABLE TO EXPLAIN HOW OR WHY THIS FAILURE COULD HAVE OCCURRED. TO THE BEST OF MY KNOWLEDGE, THERE ARE THREE CONDITIONS UNDER WHICH AN R-SERIES WILL DISPLAY A "DEFIB PAD SHORT" MESSAGE, NAMELY THE MULTI-FUNCTION CABLE IS INSERTED IN THE "SELF-TEST" PORT ON THE RIGHT SIDE OF THE DEVICE, THE MULTI-FUNCTION CABLE IS CONNECTED TO HARD PADDLES THAT ARE IN THE CRADLES ON THE SIDES OF THE DEVICE AND THE MULTI-FUNCTION CABLE IS CONNECTED TO A SET OF ONESTEP ELECTRODES WITH THE "JUMPER WIRE" IN PLACE. WE CAN RULE OUT CONDITIONS 1 AND 2 AS THE VIDEO CLEARLY SHOWS THAT THE MULTI-FUNCTION CABLE WAS PRE-CONNECTED TO THE ONESTEP ELECTRODES. IT IS HARD TO UNDERSTAND HOW CONDITION 3 COULD HAVE OCCURRED SINCE THE NURSE WHO OPENED THE PACKAGE STATED THAT SHE WAS CAREFUL TO OPEN THE PACKAGE CORRECTLY AND, LATER, HAD A SECOND RN VERIFY THAT THE PACKAGE WAS OPENED CORRECTLY. ADDITIONALLY, THE PACKAGING FROM THE ELECTRODES SHOWS THAT THE "JUMPER WIRE" HAS BEEN REMOVED FROM THE OTHER SIDE OF THE PACKAGE, AND I HAVE NO REASON TO THINK THAT THE "JUMPER WIRE" WAS REMOVED AFTER THE FACT. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MEDICAL DEFIBRILLATOR MKJ ZOLL MEDICAL CORP R-SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R