BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODE PEDIATRIC 4.5X6.25 DEFIB ZOLL

    MDR report key: 8482428 · Received April 4, 2019

    Report

    Report Number
    1219103-2019-00231
    Event Type
    Death
    Date Received
    April 4, 2019
    Date of Event
    February 15, 2019
    Report Date
    June 12, 2019
    Manufacturer
    COVIDIEN
    Product Code
    DRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INFORMATION RECEIVED THAT THE PATIENT HAD DIED. ADDITIONAL INFORMATION RECEIVED REGARDING THE INCIDENT. NEW INFORMATION WAS RECEIVED APRIL 29, 2019. TYPE OF REPORTABLE EVENT CHANGED TO DEATH. PATIENT CODE ADDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR THE PRODUCTION LOT NUMBER WAS REVIEWED FOR ANY PROBLEMS AND DISPARITIES. A DHR REVIEW PROVIDES INFORMATION THAT COULD REVEAL ANY UNUSUAL CIRCUMSTANCES THAT MAY HAVE LED TO THE ISSUE AT HAND. ALL PROCESS PARAMETERS, PRODUCT, RAW MATERIALS, AND SUB-ASSEMBLY COMPONENTS MET THE REQUIRED ACCEPTANCE CRITERIA TO COMPLETELY SATISFY THE MANUFACTURING REQUIREMENTS PER THE PRODUCT SPECIFICATION. TO DATE, PHYSICAL SAMPLES HAVE NOT BEEN RETURNED FOR INVESTIGATION. PICTURES SHOWING THE BURN/REDNESS EXPERIENCED WERE PROVIDED WITH THE COMPLAINT; THE BURNS/REDNESS APPEAR TO BE DIRECTLY IN THE CENTER OF THE PATIENT¿S CHEST AND FOLLOW THE RIB CAGE. THERE ARE SIX (6) STRAIGHT BURN MARKS (SKIN IRRITATION) ACROSS THE CHEST THAT APPEAR TO BE IN LINE WITH THE PATIENT¿S RIBS (PATIENTS RIBS APPEAR TO BE PROTRUDING OUTWARD). THE SKIN IRRITATION PATTERN HOWEVER NOT TYPICAL, APPEARS TO BE WHAT A PATIENT MIGHT EXPERIENCE USING A DEFIBRILLATION ELECTRODE PRODUCT IN A DEFIBRILLATION PROCEDURE IF THE PADS ARE NOT FULLY ADHERED TO THE PATIENT, I.E. ONLY MAKING CONTACT TO THE PROTRUDING RIBS (DUE TO EMACIATED CHEST). THE CUSTOMER REPORTED SPARKING, THIS WAS MOST LIKELY A RESULT OF THE PATIENT BEING EXTREMELY THIN AND HAD PROMINENT RIBS AND THE PAD WAS NOT APPLIED WITH ENOUGH CONTACT TO THE SKIN CREATING A HIGHER SKIN RESISTANCE. THE AREAS WITHOUT CONTACT (AIR POCKETS/TENTING) ALLOWED THE ENERGY (SPARKING) TO BE SEEN AS IT WAS DELIVERED TO THE PATIENT. SECONDLY, PEOPLE WITH FRAGILE OR SENSITIVE SKIN SUCH AS THOSE WITH VERY FAIR COMPLEXIONS, INFANTS, THE ELDERLY, POORLY NOURISHED OR DEHYDRATED PATIENTS (PATIENT WAS REPORTED TO BE ANORECTIC) AND THOSE ON MEDICATIONS THAT ALTER SKIN INTEGRITY ARE MORE SUSCEPTIBLE TO SKIN BURNS. IT IS IMPORTANT TO NOTE THAT THESE ELECTRODES PROVIDE A REDUCED SKIN IRRITATION, BUT DO NOT ELIMINATE SKIN IRRITATION. ERYTHEMAS, BURNS, AND EVEN BLISTERS WHILE NOT DESIRABLE, ARE NOT AN UNCOMMON CONSEQUENCE OF DEFIBRILLATION/CARDIOVERSION. DEFIBRILLATION/CARDIOVERSION REQUIRES HIGH INTENSITY ELECTRICAL ENERGY TO BE DELIVERED TO THE BODY THROUGH THE SKIN, WHICH GENERATES HEAT AT THE CONTACT SITE. REPEATED SHOCKS OF ESCALATING ENERGY, OFTEN REQUIRED FOR A SUCCESSFUL DEFIBRILLATION/CARDIOVERSION, WILL EXACERBATE THE UNDESIRABLE SIDE EFFECTS OF THERAPY. IT SHOULD BE NOTED THAT CONDUCTIVE PRINTED GRADIENT DESIGN REDUCES THE PROBABILITY AND EXTENT OF IRRITATION RESULTING FROM DEFIBRILLATION, BUT IT DOES NOT ELIMINATE IT. CARE SHOULD BE TAKEN TO PROPERLY PREPARE THE PATIENT SKIN PRIOR TO ELECTRODE APPLICATION AND SPECIAL CONSIDERATION SHOULD BE GIVEN TO THE ELECTRODES AND WIRES WHILE WORKING AROUND A PATIENT OR MOVING A PATIENT SO THAT THE ELECTRODES ARE NOT DAMAGED. TO HELP THE ELECTRODE MAKE GOOD SKIN CONTACT AND TO HELP REDUCE CONTACT IMPEDANCE THE PRODUCT LABELING INSTRUCTIONS AND WARNINGS SHOULD BE FOLLOWED: REMOVE EXCESS HAIR. CLEAN AND DRY SKIN SITES. DO NOT USE ALCOHOL OR TINCTURE OF BENZOIN. POSITION ELECTRODES PER THE FIGURES PROVIDED ON THE PACKAGING. IF POSSIBLE, DO NOT PLACE ELECTRODES ON BROKEN SKIN. SMOOTH THE ELECTRODE FROM THE CENTER OUTWARD TO THE EDGES WITH FINGERTIPS TO ENSURE THAT THERE ARE NO AIR POCKETS BETWEEN THE GEL AND THE PATIENT'S SKIN. ELECTRODES ARE NOT REPOSITIONABLE. REPLACE WITH NEW ELECTRODES IF REPOSITIONING IS REQUIRED. THIS WILL ENSURE OPTIMAL ADHESION AND MINIMIZE POTENTIAL PATIENT SKIN BURNS. REMOVE THE ELECTRODES FROM THE PATIENT BY SLOWLY PEELING PAD FROM THE PATIENT¿S SKIN. DO NOT DISCHARGE HAND-HELD PADDLES THROUGH THESE ELECTRODES. DO NOT OPEN PACKAGE UNTIL IMMEDIATELY PRIOR TO USE. DO NOT USE IF ELECTRODE OR POUCH IS DAMAGED. IMPORTANT: REPLACE THE ELECTRODE PADS AFTER 24 HOURS ON SKIN OR 50 DEFIBRILLATION SHOCKS. USE SEPARATE ECG ELECTRODES WHEN PERFORMING NONINVASIVE PACING. IT IS IMPORTANT THAT THE OPERATOR BE THOROUGHLY FAMILIAR WITH THE ELECTRODE OPERATING INSTRUCTIONS AND WARNINGS PRIOR TO USE. FAILURE TO COMPLY WITH THE PRODUCT INSTRUCTIONS FOR USE OR WARNINGS MAY INCREASE THE LIKELIHOOD OF A PATIENT EXHIBITING SKIN IRRITATION. BIOCOMPATIBILITY STUDIES ARE PERFORMED ON THE ADHESIVE FOAM AND GELS ACCORDING TO THE GUIDELINES DEFINED IN THE ISO STANDARDS. EACH GEL AND ELECTRODE MANUFACTURED IN THE FACILITY MUST PASS CYTOTOXICITY, PRIMARY SKIN IRRITATION AND SKIN SENSITIZATION TESTING BEFORE IT IS DISTRIBUTED FOR COMMERCIAL SALE. EACH HYDROGEL OFFERED FOR SALE HAVE PASSED ALL THREE TESTS TO ENSURE THE HIGHEST QUALITY MEDICAL HYDROGELS AVAILABLE. THE COMPLETE REPORTS ARE AVAILABLE UPON REQUEST. IN ADDITION, ALL HYDROGELS MANUFACTURED AS THIS FACILITY MUST COMPLY WITH ISO STANDARDS. SKIN REACTION SUCH AS THOSE EXPERIENCED BY THE PATIENT COULD BE THE RESULT OF AN ACUTE SENSITIZATION RESPONSE TO THE MATERIAL COMPONENTS THAT MAKE UP THE ELECTRODE. ALL MATERIALS HAVE BEEN DEEMED SAFE AND EFFECTIVE FOR USE PER THE ISO STANDARDS. THE RESULTS OF THE MANUFACTURING FACILITY INVESTIGATION WERE UNABLE TO ATTRIBUTE ANY POTENTIAL ROOT CAUSES ASSOCIATED WITH THE MANUFACTURE OF PRODUCT WHICH WOULD HAVE CONTRIBUTED TO THE SUSCEPTIBILITY OF SKIN IRRITATION. BASED UPON THE INVESTIGATIVE DETAILS AND THE ROOT CAUSE EVALUATION, NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME IN RELATION TO THE CUSTOMER DESCRIBED EVENT. WE WILL CONTINUE TO TREND THIS DEFECT FOR FUTURE OCCURRENCES AS PART OF THE COMPLAINT REVIEW PROCESS.

    Description of Event or Problem · 0

    THE CUSTOMER STATES AN ANORECTIC PATIENT NEEDED TO BE CARDIOVERTED DUE TO A TACHYCARDIC ATRIAL FIBRILLATION. THE PADS WERE PLACED AND THE PATIENT RECEIVED ONE SHOCK OF ABOUT A MILLISECOND AS USUAL PROCEDURE. AT THE DELIVERY OF THE 120J SHOCK, SPARKING OCCURRED AT THE JUNCTION OF THE PAD TO THE CABLE. SMELL OF A BURN OCCURRED AFTERWARDS. AFTER THE REMOVAL OF THE ELECTRODES, SKIN HAD VISIBLE DAMAGE. THERE WAS NO MEDICAL INTERVENTION REQUIRED FOR THE SKIN DAMAGE. THE PATIENT WAS EXTREMELY ILL DUE TO CHRONIC ILLNESS. THE PATIENT DIED 12 HOURS LATER.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEFIB PADS WERE PLACED AND AT THE DELIVERY OF 120 J SHOCK, SPARKING OCCURRED AT THE JUNCTION FROM THE PAD TO THE CABLE. A BURNING SMELL WAS NOTICED AND WHEN THE ELECTRODES WERE REMOVED, THE PATIENT'S SKIN SHOWED IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275901 ELECTRODE PEDIATRIC 4.5X6.25 DEFIB ZOLL PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) DRO COVIDIEN 22770R 826950X

    Patients

    Seq Age Sex Outcome Treatment
    1 Death