BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN DEFIBRILLATION PADS

    MDR report key: 2974903 · Received February 22, 2013

    Report

    Report Number
    1320894-2013-00021
    Event Type
    Death
    Date Received
    February 22, 2013
    Date of Event
    June 8, 2012
    Report Date
    February 22, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    LDD
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION IS A MFE, MULTI-FUNCTION ELECTRODE INTENDED FOR USE DURING DEFIBRILLATION, CARDIOVERSION, PACING, AND ECG MONITORING APPLICATIONS. THERE IS NO DEVICE AVAILABLE FOR EVALUATION, NO CATALOG NUMBER AND NO LOT NUMBER FOR THE DEVICE WERE MADE AVAILABLE. CONMED CORPORATION IS NOT ABLE TO CONFIRM THAT A CONMED MANUFACTURED PRODUCT WAS INVOLVED IN THIS INCIDENT. THIS EVENT OCCURRED ON (B)(6) 2012, AND WAS REPORTED TO CONMED CORPORATION, BY PHYSIO-CONTROL, ON (B)(6) 2013 (EIGHT MONTHS AFTER THE INCIDENT). (B)(6) HAD REPORTED THIS INCIDENT TO PHYSIO-CONTROL DUE TO THE LIFE-PAK 12 "MIS-FIRING"; HOWEVER, THEY HAD NEVER REPORTED THIS INCIDENT TO CONMED CORPORATION. I REVIEWED THE MINIMAL ASPECTS OF THE INCIDENT THAT PHYSIO-CONTROL SHARED DURING COMMUNICATIONS WITH (B)(6) PARAMEDIC. (B)(6) FIRST QUESTION OF ME ASKED HOW DID PHYSIO-CONTROL DETERMINE THAT A CONMED MFE WAS INVOLVED IN THE INCIDENT? PER (B)(6) THERE IS NO DOCUMENTATION AS TO WHAT BRAND OF DEFIB PAD WAS UTILIZED IN THE INCIDENT. (B)(6) ALSO STATED THAT, "NOTHING IS CONSTANT (REFERRING TO DISPOSABLE MEDICAL ITEMS). THE DEFIB PADS USED ANY DAY CAN CHANGE AND THAT DEPENDS ON WHAT IS AVAILABLE AND WHO IS SELLING THE MOST COST EFFECTIVE DEVICES FOR OUR BUDGET." THERE IS NO CONCLUSIVE EVIDENCE THAT A CONMED MFE DEVICE WAS UTILIZED IN THE REPORTED INCIDENT. THE PARAMEDIC INVOLVED IN THE AMBULANCE RUN CANNOT CONFIRM WHETHER OR NOT A CONMED DEFIB PAD WAS UTILIZED DURING THE REPORTED INCIDENT. REVIEWING THE (B)(6) DOCUMENTATION OF THE AMBULANCE RUN # (B)(6), UNIT # 47, ON (B)(6) 2012, THE NOTES SHOW THAT THE EMS CREW WERE FOLLOWING THEIR ALS, ADVANCED LIFE SUPPORT, PROTOCOLS. THE DOCUMENTATION STATES, "VENTRICULAR TACHYCARDIA PROGRESSED TO V-FIB. PACER/DEFIB PADS APPLIED. V-FIB CONTINUED. MONITOR CHARGED FOR DEFIB - SHOCK MACHINE MISFIRED. ASSISTANCE REQUESTED, V-FIB CONTINUED, CHARGED TO 200 JOULES AND ADMINISTERED SHOCK. (RHYTHM CHANGED TO) ASYSTOLE." THE NOTES THEN SHOW THE CONTINUANCE OF ALS PROTOCOLS WITHOUT ANY CHANGE TO THE CARDIAC RHYTHM (REMAINED ASYSTOLIC). I ASKED THE PARAMEDIC, JAMES POWERS, IF THE PATIENT WOULD HAVE DECEASED IN THIS INCIDENT DESPITE THE ALS EFFORTS PERFORMED, OR, IF THE DEATH WAS BEING BLAMED ON ANY EQUIPMENT FAILURE. THE PARAMEDIC CHOSE TO NOT MAKE A STATEMENT ON WHETHER OR NOT THE PATIENT'S DEATH WAS INEVITABLE REGARDING THE SITUATION THAT PRESENTED DURING THE INCIDENT; HOWEVER, HE ALSO STATED THAT THERE WAS NOT ANY EQUIPMENT FAILURE EXCEPT FOR THE LIFE-PAK 12 MISFIRING ON THE FIRST ATTEMPT TO DEFIBRILLATE. THE CARDIAC STRIPS SENT TO CONMED CORPORATION BY WHITLEY COUNTY EMS SHOW THE MFE'S CAPTURING ECG RHYTHMS OF THE INCIDENT AND THE PATIENT RECEIVED DEFIBRILLATION SHOCK WHEN THE DEFIBRILLATOR WAS FIRED (SECOND ATTEMPT). AFTER THE DELIVERED DEFIBRILLATION THE PATIENT'S CARDIAC RHYTHM DETERIORATED TO ASYSTOLE AND REMAINED THERE. THIS RHYTHM WAS CAPTURED APPROPRIATELY BY THE MFE PADS UTILIZED. THIS RHYTHM WAS A NON-SHOCKABLE RHYTHM. FROM THE EMS DOCUMENTATION OF THE INCIDENT THERE IS NO EVIDENCE SHOWN THAT THE DEFIBRILLATION PADS UTILIZED (BRAND UNKNOWN) EVER FAILED TO FUNCTION. NO PRODUCT WAS RETURNED FOR EXAMINATION OR CONFIRMATION OF DEFECT OR CONMED PRODUCT. NO ROOT CAUSES CAN BE CONFIRMED WITHOUT EXAMINATION OF THE ACTUAL PRODUCT; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    THE FOLLOWING INCIDENT WAS REPORTED TO CONMED CORPORATION BY PHYSIO-CONTROL. THE REPORTED INCIDENT INVOLVES THE USE OF CONMED MULTIFUNCTION DEFIBRILLATION ELECTRODES. IT WAS REPORTED THAT THE CUSTOMER ((B)(6)) RESPONDED TO A (B)(6) MALE PATIENT WITH A HISTORY OF HIGH BLOOD PRESSURE. WHEN THE CUSTOMER ARRIVED THE PATIENT HAD A SINUS TACHYCARDIA RHYTHM AND CONVERTED INTO A VENTRICULAR TACHYCARDIA RHYTHM. AFTER A SHORT PERIOD OF TIME, THE PATIENT CONVERTED INTO A VENTRICULAR FIBRILLATION RHYTHM. AT THIS TIME CONMED BRAND DEFIBRILLATION ELECTRODES WERE APPLIED TO THE PATIENT. THE CUSTOMER WAS UNABLE TO MONITOR THE PATIENT MULTIPLE TIMES. AN ANALYSIS WAS PERFORMED AFTER APPROXIMATELY THREE (3) MINUTES AND A 200 JOULE SHOCK WAS DELIVERED. SUBSEQUENT ANALYSIS OF THE PATIENT RESULTED IN "NO SHOCK ADVISED" DECISIONS. THE PATIENT WAS NOT RESUSCITATED. CONMED ASKED PHYSIO-CONTROL IF THERE WERE ANY PHOTOGRAPHS OF -OR- IF THE ACTUAL "CONMED DEFIBRILLATION ELECTRODES" INVOLVED IN THE INCIDENT HAD BEEN RETURNED TO THEM. PHYSIO-CONTROL ANSWERED BY EMAIL THAT, "NEITHER PHOTOGRAPHS OF THE CONMED ELECTRODES OR THE ELECTRODES THEMSELVES WERE PROVIDED TO PHYSIO-CONTROL." CONMED ALSO ASKED NUMEROUS QUESTIONS OF PHYSIO-CONTROL REGARDING DETAILS SURROUNDING THE INCIDENT. AGAIN, ANSWERING VIA EMAIL PHYSIO-CONTROL RESPONDED, "THE OTHER INFORMATION YOU HAVE REQUESTED IS PROPRIETARY AND CONFIDENTIAL TO PHYSIO-CONTROL. OUR INVESTIGATION WAS CONDUCTED IN AN ATTORNEY-CLIENT PRIVILEGED MANNER. IT IS FOR THESE REASONS THAT WE WILL BE UNABLE TO COMPLY WITH YOUR REQUEST FOR ANY ADDITIONAL INFORMATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78815 UNKNOWN DEFIBRILLATION PADS MULTI-FUNCTION ELECTRODES LDD CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death