BEUDAMED
    FDA Adverse Event Death Summary report: N

    R2 MULTIFUNCTION ELECTRODE CABLE, HEARTSTART XL TO R2

    MDR report key: 3674802 · Received March 12, 2014

    Report

    Report Number
    1320894-2014-00025
    Event Type
    Death
    Date Received
    March 12, 2014
    Date of Event
    February 4, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CONMED CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE R2 MFE, MULTI-FUNCTION ELECTRODE CABLE, HEARTSTART XL TO R2, ACTS AS AN INTERFACE BETWEEN THE DEFIBRILLATOR OR ADAPTOR MODULE AND THE R2 MULTIFUNCTION ELECTRODES, MFE, ENABLING THE R2 MFES TO BE USED WITH EXISTING EQUIPMENT FOR DEFIBRILLATION, NONINVASIVE TEMPORARY PACING, ECG MONITORING AND SYNCHRONIZED CARDIOVERSION. (DEPENDING ON THE FUNCTIONS OF THE HOST DEVICE). THIS PRODUCT IS A REUSABLE DEVICE. A REVIEW OF THE MANUFACTURING DOCUMENTS FROM THE DHR/LHR FOR (B)(4) WAS NOT ACCOMPLISHED AS THE LOT NUMBER WAS NOT PROVIDED, AND, THE LOT NUMBER ON THE TAG ATTACHED TO THE CABLE IS ILLEGIBLE. THE ORIGINAL ADAPTOR CABLE UTILIZED IN THE REPORTED INCIDENT WAS RETURNED TO CONMED FOR EVALUATION. EXAMINATION OF ONE (1) (B)(4) R2 PAD MARKED "ORIGINAL PRODUCT THAT WAS USED IN INCIDENT": THE R2 ADAPTOR CABLE RETURNED BY THE CUSTOMER WAS NOT ABLE TO CONNECT TO THE R2 PAD CONNECTOR. A SAMPLE R2 MALE ADAPTOR WAS OBTAINED FROM MARKETING DEPARTMENT AND WAS ABLE TO CONNECT TO THIS COMPLAINT DEVICE. EXAMINATION OF TWO (2) (B)(4) R2 PADS MARKED "UNOPENED": BOTH PACKAGES HAD LOT #1308074. ONE (1) PACKAGE WAS OPENED AS RECEIVED. THE CUSTOMER'S R2 ADAPTOR CABLE WAS ABLE TO CONNECT TO THE CONNECTOR. ONE (1) PACKAGE WAS UNOPENED AS RECEIVED. THE CUSTOMER'S R2 ADAPTOR CABLE WAS NOT ABLE TO BE CONNECTED TO THE R2 PAD CONNECTOR. THE SAMPLE R2 MALE ADAPTOR FROM MARKETING AND WAS ABLE TO CONNECT TO BOTH COMPLAINT DEVICES. THE COMPLAINT DEVICES WERE ALSO EVALUATED BY THE PROJECT ENGINEER FOR R2 PADS. HE STATED THAT THE CONNECTOR CONTACT TUBES WERE DESIGNED SO THAT THEY "FLOAT" IN THE CONNECTOR. THIS ALLOWS THE PINS ON THE MALE CONNECTOR ENOUGH PLAY TO SEAT IN THE CONTACT TUBES; EVEN IF THE PINS ARE NOT EXACTLY STRAIGHT OR ALIGNED. THEREFORE, THE OBSERVED SKEWED CONTACT TUBES ARE NOT CONSIDERED A DEFECT. WIRE SETS ((B)(4)) FROM TWO (2) DIFFERENT LOTS OF CURRENT INVENTORY WERE OBTAINED FROM THE CONMED (B)(4) FACILITY FOR EXAMINATION AND TESTING. A SAMPLE R2 MALE ADAPTOR WAS OBTAINED FROM MARKETING DEPARTMENT TO EVALUATE THE FIT WITH THE WIRE SETS. ALL OF THE WIRE SETS FIT PROPERLY WITH THE SAMPLE R2 ADAPTOR. THE INCIDENT ADAPTOR CABLE WAS THEN USED TO CONNECT TO THE WIRE SETS AND ONLY 31% CONNECTED. IN SUMMARY, EVIDENCE SUGGESTS THAT THE CAUSE OF THIS COMPLAINT IS AN ANOMALY ON ONE (1) OF THE CONTACT PINS ON THE ORIGINAL ADAPTOR CABLE USED IN THE INCIDENT. A PIN IN THE ADAPTOR WAS FOUND AS BENT. THIS RESULTED IN THE PIN FORM THE MFE CATCHING ON A CONTACT TUBE IN THE R2 PAD CONNECTOR. THEREFORE, THIS COMPLAINT FOR THE R2 ADAPTOR CABLE (B)(4) WAS CONFIRMED. TO MITIGATE THIS TYPE OF FAILURE, THE CABLE CONVERTER/SUPPLIER UTILIZES 100% VISUAL INSPECTION AND FUNCTIONAL TESTING TO VERIFY FORM AND FIT OF THE MATING CONNECTORS. THEREFORE, IT IS UNLIKELY THAT A DEFECTIVE R2 PAD CONNECTOR WOULD BE RELEASED. CONVERSATIONS WITH THE NURSING STAFF OF THE END-USER FACILITY REVEALED THAT ALL DEFIBRILLATORS WITHIN THE END-USER FACILITY ARE EQUIPPED WITH DEFIBRILLATOR PADDLES, AND, THE NURSING STAFF ARE TRAINED IN THE USE OF DEFIBRILLATOR PADDLES. THE PATIENT HAD ARRIVED WITH THE R2 MFE IN PLACE SO THE STAFF INITIALLY ATTEMPTED TO USE THE R2 MFE PADS. HOWEVER, AN ALTERNATIVE DEFIBRILLATION SOURCE WAS READILY AVAILABLE FOR UTILIZATION ON THE PATIENT. THE NURSING STAFF ALSO DO NOT FEEL THAT THE PATIENT DEATH WAS NOT THE DIRECT RESULT OF THE REPORTED DEFECTIVE DEVICE. DUE TO THE LOT OF THE DEVICE BEING UNKNOWN, THERE IS NO WAY OF KNOWING THE AGE OF THE REUSABLE DEVICE. THERE IS NO DEFINED LIFESPAN OF THIS DEVICE, AND, WITH NORMAL USE THE DEVICE WILL EXHIBIT WEAR AND TEAR AS IT AGES. THE IFU, INSTRUCTIONS FOR USE, STATES TO, "CHECK CONNECTOR END OF PATIENT CABLE PRIOR TO USE. DO NOT USE IF CONNECTOR PINS ARE DAMAGED." THE COMPLAINT INVESTIGATION HAS NOT CONCLUSIVELY IDENTIFIED A MANUFACTURING RELATED DEFECT WITH THE R2 MULTIFUNCTION ELECTRODE CABLE. IN ADDITION, A REVIEW OF THE CUSTOMER COMPLAINTS FOR THE PAST TWENTY-FOUR (24) MONTHS FOR R2 MFE PADS AND ADAPTORS SHOWS THIS AS AN ISOLATED INCIDENT. THEREFORE, CORRECTIVE ACTION IS NOT WARRANTED AT THIS PRESENT TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. THIS MEDWATCH IS ASSOCIATED WITH MEDWATCH 1320894-2014-00024 THAT WAS SUBMITTED FOR THE R2 MFE UTILIZED IN THIS INCIDENT.

    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 COMMENCED. UPON COMPLETION OF THE QUALITY ENGINEERING EVALUATION A SUPPLEMENTAL REPORT WILL BE FILED. THIS MEDWATCH IS ASSOCIATED WITH MEDWATCH REPORT NUMBER 3007305485-2014-00024 FILED FOR THE (B)(4) PAD THAT WAS UTILIZED IN THIS REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "A NURSE WAS USING OUR R2 PADS TO DEFIBRILLATOR A (B)(6) AND SHE WAS NOT ABLE TO CONNECT THE PADS INTO THE PLUG BECAUSE THE WIRES IN THE PLUG WERE BENT. SHE FEELS THAT THEY WERE TOO EASY TO BEND. THEN THEY DID A SERIES OF TESTS IN THE ICU WITH THE REMAINING PADS. AND THEY THOUGHT THEY WERE ABLE TO DESTROY THEM TOO EASILY." THIS OCCURRED IN THE HOSPITAL EMERGENCY DEPARTMENT. THE PATIENT CAME IN AND THEY WERE UNABLE TO CONNECT THE PADS THAT WERE ON THE PATIENT TO THEIR DEFIBRILLATOR. THIS REPORT IS FOR THE ADAPTOR CABLE UTILIZED BETWEEN THE (B)(4) PADS AND THE DEFIBRILLATOR. THE PATIENT ASSOCIATED WITH THIS INCIDENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148208 R2 MULTIFUNCTION ELECTRODE CABLE, HEARTSTART XL TO R2 R2 ADAPTOR CABLE MKJ CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death