BEUDAMED
    FDA Adverse Event Death Summary report: N

    1310P MEDITRACE 2/PK 20/CA

    MDR report key: 2255135 · Received September 16, 2011

    Report

    Report Number
    9681860-2011-00008
    Event Type
    Death
    Date Received
    September 16, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 17, 2011
    Manufacturer
    COVIDIEN
    Product Code
    DRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE 09/16/2011. AN INVESTIGATION IS UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 BY (B)(6), (B)(6) POST MARKET SURVEILLANCE SPECIALIST FROM PHYSIO CONTROL THAT A CUSTOMER HAD AN ISSUE WITH A DEFIBRILLATION ELECTRODE. (B)(6) REPORTS THAT HE RECEIVED A COMPLAINT FROM (B)(6) FIRE DEPARTMENT AND (B)(6) EMS. IT WAS REPORTED TO (B)(6) THAT MEDICAL PERSONNEL WERE CALLED TO THE RESIDENCE OF A (B)(6) MALE THAT HAD BEEN UNSEEN FOR 10 MIN PRIOR TO BEING FOUND "BLUE" ON THE FLOOR. THE CALL CAME IN AT 14:12, THE FIRST RESPONDERS (B)(6) ARRIVED APPROXIMATELY 5 MIN LATER AND BEGAN CPR. THEY CONNECTED A LIFEPAK 1000 DEFIBRILLATOR TO THE PT ALONG WITH KENDALL MEDI-TRACE ELECTRODES. THEY REPORTED RECEIVING MULTIPLE "CONNECT ELECTRODES" WARNING MESSAGES AND WERE NOT ABLE TO SHOCK THE PT. THE PT WAS NOTED TO HAVE EXCESSIVE HAIR SO THEY "ROUGHLY" SHAVED THE CHEST. CPR WAS CONTINUED UNTIL THE ARRIVAL OF (B)(6) EMS AT 14:22. AT THAT TIME, EMS CONNECTED A LIFEPAK 15 MONITOR/DEFIBRILLATOR TO THE SAME KENDALL MEDI-TRACE ELECTRODES AND PROCEEDED TO SUCCESSFULLY DELIVER ONE SHOCK OF 200 JOULES. THE MEDIC BEGAN SEEING "DASH LINES" ON THE MONITOR AND CHANGED THE ELECTRODES TO ANOTHER SET OF KENDALL MEDI-TRACE ELECTRODES. THE FAILURE PERSISTED AND AT THAT TIME, IT WAS DECIDED TO CHANGE BACK TO THE LIFEPAK 1000 DEFIBRILLATOR. THE PT WAS THEN SUCCESSFULLY SHOCKED TWO MORE TIMES WITH 200 JOULES AND THEN 300 JOULES. AT THIS TIME, A THIRD DEFIBRILLATOR (LIFEPAK12) WAS BROUGHT TO THE SCENE AND CONNECTED TO THE EXISTING, (2ND) SET OF KENDALL MEDI-TRACE ELECTRODES. THERE WERE NO PROBLEMS REPORTED WITH THE CONNECTION OR THE DEFIBRILLATOR, HOWEVER, NO SHOCKS WERE DELIVERED AND THE PT WAS NOT RESUSCITATED. THE ECG RECORDINGS FROM THE DEFIBRILLATORS INDICATE A DELAY OF APPROXIMATELY 1 MINUTE AND 45 SECONDS FROM INITIAL CONNECTION TO DEFIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1310P MEDITRACE 2/PK 20/CA DEFIBRILLATION PADS DRX COVIDIEN 31319281 035109

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death