BEUDAMED
    FDA Adverse Event Death Summary report: N

    R2MULTIFUNCTION ELECTRODES, MFE, R2 CONNECTOR

    MDR report key: 3896937 · Received June 26, 2014

    Report

    Report Number
    3007305485-2014-00072
    Event Type
    Death
    Date Received
    June 26, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 3, 2014
    Manufacturer
    CONMED CORPORATION
    Product Code
    LDD
    PMA / PMN Number
    K964469
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    THREE (3) "USED" 3200-1715 ADULT R2 MULTI-FUNCTION ELECTRODE PADS WERE RETURNED FOR EVALUATION ON JUNE 11, 2014. THE EVALUATIONS AND INSPECTIONS OF THE RETURNED DEVICES ARE AS FOLLOWS: AN EVALUATION OF THE RETURNED UNIT ONE (1) FOUND THE "USED" DEVICE WAS MARKED AS "GOOD PAD #3". VISUAL INSPECTION FOUND ONE (1) CONTACT SOCKET WAS NOT CENTER AND THE SECOND SOCKET WAS SLIGHTLY OFF CENTER (SEE NOTE BELOW). THERE ARE TWO (2) CONTACT SOCKETS IN (B)(4) CONNECTORS. THE TEST SAMPLE R2 MALE ADAPTOR WAS ABLE TO ATTACH EASILY AND PROPERLY TO THE RETURNED DEVICE CONNECTOR. THE CONNECTOR HOUSING WAS DISMANTLED AND THE SOCKETS WERE FOUND TO PULL OUT OF THE CONNECTOR WITH MINIMAL FORCE. HOWEVER, THIS DID NOT PREVENT OR HINDER PROPER CONNECTION BETWEEN THE SOCKETS AND THE TEST SAMPLE R2 MALE ADAPTOR. EVALUATION OF UNIT 2 FOUND THE DEVICE WAS RECEIVED WITH THE BLUE WIRE SEVERED AND THE PADS FOLDED OVER ONTO THEMSELVES. VISUAL INSPECTION FOUND ONE (1) OF THE CONTACT SOCKETS (ON THE BLUE WIRE) WAS PUSHED INTO THE CONNECTOR HOUSING AND THE OTHER SOCKET WAS SLIGHTLY OFF CENTER (SEE NOTE BELOW). ON THE CONNECTOR, WHERE THE SOCKET WAS PUSHED IN THERE WAS A BURN MARK BELIEVED TO HAVE BEEN CAUSED BY ELECTRICAL ARCING. AFTER THE CONNECTOR HOUSING WAS DISMANTLED, IT WAS NOTED THAT THE SOCKET ON THE WHITE WIRE COULD NOT BE MANUALLY PULLED OUT OF THE CONNECTOR, WHICH INDICATED THAT THE SOCKET WAS SECURELY SEATED. EVALUATION OF UNIT 3 FOUND THE DEVICE WAS RECEIVED WITH THE WHITE WIRE SEVERED AND THE PADS FOLDED TOGETHER. VISUAL INSPECTION FOUND ONE (1) OF THE CONTACT SOCKETS (ON THE BLUE WIRE) WAS PUSHED INTO THE CONNECTOR HOUSING AND THE OTHER SOCKET WAS SLIGHTLY OFF CENTER. AFTER THE CONNECTOR HOUSING WAS DISMANTLED, IT WAS NOTED THAT THE SOCKET ON THE WHITE WIRE COULD NOT BE MANUALLY PULLED OUT OF THE CONNECTOR, WHICH INDICATED THAT THE SOCKET WAS SECURELY SEATED. NOTE: THE CONNECTOR CONTACT SOCKETS WERE DESIGNED SO THAT THEY "FLOAT" IN THE CONNECTOR. THIS ALLOWS THE PINS ON THE MALE CONNECTOR ENOUGH PLAY TO SEAT IN THE CONTACT SOCKETS; EVEN IF THE PINS ARE NOT EXACTLY STRAIGHT OR ALIGNED. THEREFORE, THE OBSERVED SKEWED CONTACT SOCKETS ARE NOT CONSIDERED A DEFECT. BASED ON THE EVALUATION FINDINGS AND AVAILABLE INFORMATION, IT IS BELIEVED THAT THE DAMAGED CONTACT SOCKETS ON THE TWO RETURNED DEVICE (WHERE THE SOCKETS ON THE BLUE WIRES WERE PUSHED IN) MIGHT BE RELATED TO AN ISSUE WITH THE PLUG FROM THE END USER CABLE ADAPTOR. HOWEVER, THE CABLE THAT WAS USED TO CONNECT TO THE PAD CONNECTORS WAS NOT RETURNED FOR EVALUATION. IN THIS INSTANCE, IT IS NOT KNOWN IF THE PLUG WAS IN POOR CONDITION OR DAMAGED AND THEREFORE COULD NOT MAKE A PROPER CONNECTION, THEREBY PUTTING UNDUE FORCE ON THE CONTACT SOCKETS OF THE RETURNED PADS. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED, AS THE LOT NUMBER OF THE RETURNED DEVICES WAS NOT MADE AVAILABLE. A 2-YEAR REVIEW OF THE DEVICE COMPLAINT HISTORY FOUND ONE (1) OTHER SIMILAR COMPLAINT RECEIVED. HOWEVER, EVALUATION INTO THE REPORTED PROBLEM INDICATED THAT THE "CONNECTION PROBLEM" WAS ATTRIBUTED TO A FAULTY R2 CONNECTOR ADAPTOR AND NOT THE R2 MULTI-FUNCTION ELECTRODE PAD. DURING THE SAME 2 YEAR PERIOD, OVER 30,968 UNITS WERE SOLD WORLDWIDE, MAKING THE OCCURRENCE RATE FOR THIS FAILURE MODE 0.006 PERCENT. THE R2 MFE, MULTI-FUNCTION ELECTRODE, IS INTENDED FOR USE DURING DEFIBRILLATION, CARDIOVERSION, PACING, AND ECG MONITORING APPLICATIONS. THIS PRODUCT IS A SINGLE USE, DISPOSABLE DEVICE. TO ENSURE PROPER FUNCTION OF THE R2 MULTI-FUNCTION ELECTRODE AND TO REDUCE THE RISK OF PATIENT INJURY, THE IFU (INSTRUCTIONS FOR USE) PROVIDES THE FOLLOWING PRECAUTIONS AND WARNINGS: - BE FAMILIAR WITH THE OPERATION OF THE HOST DEVICE AND INTERFACE SYSTEMS, AND USE IN ACCORDANCE WITH MANUFACTURER'S RECOMMENDATIONS. - CHECK CABLES AND CONNECTOR PINS PRIOR TO USE. - SEVERAL DIFFERENT TYPES OF ELECTRODES AND INTERFACE SYSTEMS ARE AVAILABLE. CONFIRM THAT YOU HAVE THE CORRECT CABLE AND CORRESPONDING ELECTRODES FOR THE HOST DEVICE. THE DATE OF THIS REPORT WAS INCORRECTLY REPORTED ON THE INITIAL SUBMISSION OF THIS MEDWATCH AND IS (B)(4) 2014 AS REFLECTED IN THIS MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORTED INCIDENT HAVE BEEN RETURNED TO CONMED CORPORATION; HOWEVER, THE QUALITY ENGINEERING EVALUATION HAS NOT YET BEEN COMPLETED. I SPOKE WITH THE END-USER FACILITY REPORTER, (B)(6) 2014. HE STATED HE WAS PARAMEDIC ON SCENE WITH THIS REPORTED INCIDENT. (B)(6) RESPONDED THAT HE RESPONDED TO A FULL CARDIAC ARREST. THERE WAS AN 8 TO 10 MINUTE TRAVEL RESPONSE TIME AND THEY SPENT APPROXIMATELY 20 MINUTES ON SCENE ATTEMPTING TO STABILIZE THE PATIENT. THE PERSONNEL THAT OPENED THE DEFIB PADS DID NOT SAVE THE PACKAGES; THEREFORE, THE LOT OF THE DEVICE IS UNKNOWN. THE PLUG OF THE DEFIB PAD WAS PLUGGED INTO THE (B)(4) DEFIBRILLATOR/MONITOR AND A CARDIAC RHYTHYM FLASHED ACROSS THE SCREEN - AS HE LET GO OF THE PLUG THE MONITOR WENT FLAT LINE. THE PLUG HAD TO BE HELD INTO GET A RHYTHYM AND/OR TO DEFIBRILLATE THE PATIENT. SWITCHED MONITORS - SAME ON SECOND MONITOR - SWITCHED PADS SAME RESULT. I WAS INFORMED THAT THE PADS PLUGGED DIRECTLY INTO THE MONITOR - NO ADAPTOR ADDED. THE PATIENT WAS SUCCESSFULLY DEFIBRILLATED SIX (6) OR SEVEN (7) TIMES. THERE WAS NO DELAYS IN DEFIBRILLATING THE PATIENT EXCEPT FOR ONE ATTEMPT ON THE SIXTH OR SEVENTH ATTEMPT AND THEY WERE WELL INTO THE CARDIAC ARREST WHEN THIS OCCURRED. THE PROBLEM EXPERIENCED WITH THE R2 PADS, IN THE OPINION OF THE SCENE PARAMEDIC, DID NOT CHANGE THE PATIENT OUTCOME. THE PATIENT WAS NOT RESPONDING TO ANY RESUSCITATION ATTEMPTS THAT WERE ADMINISTERED (ELECTRICAL SHOCK, CPR, AND OR PHARMACEUTICALS ADMINISTERED). THE R2 PAD PLUG WAS EXAMINED AFTER THE CARDIAC ARREST (BY THE EMS PERSONNEL) AND IT WAS NOTICED THAT ONE OF THE METAL SLEEVES WITHIN THE PLUG THAT CONNECTS OVER A PIN IN THE DIFIBRILLATOR PLUG WAS PUSHED BACK INTO THE R2 PLUG - THE ONLY ELECTRICAL CONNECTION POSSIBLE WAS TO HOLD THE PLUG PUSHED INTO THE MONITOR. HE ALSO MENTIONED THAT THEY EXAMINED THE INPUT AREA ON THE DEFIBRILLATORS AND THE PINS VISUALLY APPEARED TO BE CENTERED AND NOT BENT. GARY ALSO MENTIONED THAT THERE WERE SO MANY WIRES AND TUBES IN THE MIX THAT THE PAD THAT FAILED IS CUT ON ONE WIRE TO IDENTIFY IT AS A NON FUNCTIONING CABLE WITHOUT REMOVING IT FROM THE PATIENT VICINITY DURING THE ARREST. UPON COMPLETION OF THE QUALITY ENGINEERING EVALUATION A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "CORDS DID NOT WORK AT THE PLUG INTO THE MACHINE. THE METAL PRONG INSIDE THE PLUG WAS PUSHED BACK INTO THE PLUG OR CORD AND IT WOULD NOT MAKE CONNECTION. YOU HAD TO HOLD IT." THIS OCCURRED IN THE FIELD WITH THE HOSPITAL EMS PERSONNEL. THE PATIENT ASSOCIATED WITH THIS INCIDENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374799 R2MULTIFUNCTION ELECTRODES, MFE, R2 CONNECTOR R2 MFE / DEFIB PADS LDD CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death