BEUDAMED
    FDA Adverse Event Death Summary report: N

    R2MULTIFUNCTION ELECTRODES, MFE, R2 CONNECTOR

    MDR report key: 3674735 · Received March 12, 2014

    Report

    Report Number
    3007305485-2014-00024
    Event Type
    Death
    Date Received
    March 12, 2014
    Date of Event
    February 4, 2014
    Report Date
    May 19, 2014
    Manufacturer
    CONMED CORPORATION
    Product Code
    LDD
    PMA / PMN Number
    K964469
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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 1320894-2014-00025 FILED FOR THE ADAPTOR CABLE FOR THE MFE PAD THAT WAS UTILIZED IN THIS REPORTED INCIDENT.

    Additional Manufacturer Narrative · 1

    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. A REVIEW OF THE MANUFACTURING DOCUMENTS FROM THE DHR/LHR FOR (B)(4) LOT 1308074 HAS VERIFIED THE DEVICES WERE PRODUCED AND RELEASED ACCORDING TO THE CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. PROPER MANUFACTURING PROCEDURES INCLUDING TESTING AND INSPECTIONS WERE PERFORMED DURING MANUFACTURE TO PREVENT NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS AND PERFORMANCE. EXAMINATION OF ONE (1) (B)(4) PAD MARKED "ORIGINAL PRODUCT THAT WAS USED IN INCIDENT": BOTH OF THE METAL TUBE CONTACTS ON THE CONNECTOR APPEARED SKEWED, I.E., NOT CENTERED. 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) PADS MARKED "UNOPENED": BOTH PACKAGES HAD LOT #1308074. ONE (1) PACKAGE WAS OPENED AS RECEIVED. BOTH CONTACTS APPEARED CENTERED. THE CUSTOMER'S R2 ADAPTOR CABLE WAS ABLE TO CONNECT TO THE CONNECTOR. ONE (1) PACKAGE WAS UNOPENED AS RECEIVED. BOTH OF THE METAL TUBE CONTACTS ON THE CONNECTOR APPEARED SKEWED. 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. EXAMINATION OF TWO (2) (B)(4) PADS MARKED "CONTAMINATED": ON BOTH DEVICES, ONE (1) OF THE METAL TUBE CONTACTS HAD BEEN UNSEATED AND LOCATED INSIDE THE CONNECTOR HOUSING AS IF PUSHED IN. 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)(6) FACILITY FOR EXAMINATION AND TESTING. VISUAL EXAMINATION OF ALL OF THE WIRE SETS FOUND THAT 54% OF THE CONNECTORS HAD SKEWED CONTACT TUBES. 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 CUSTOMERS ADAPTOR CABLE WAS THEN USED TO CONNECT TO THE WIRE SETS AND ONLY 31% CONNECTED. HOWEVER, NO CORRELATION WAS FOUND BETWEEN THE POSITION OF THE CONTACT TUBES IN THE CONNECTOR AND THE ABILITY TO CONNECT TO THE CUSTOMER'S ADAPTOR CABLE. IN SUMMARY, EVIDENCE SUGGESTS THAT THE CAUSE OF THIS COMPLAINT WAS NOT DUE TO A DEFECTIVE R2 PAD; THEREFORE, THE COMPLAINT REGARDING THE R2 PADS (B)(4) WAS CONSIDERED NOT CONFIRMED. TO MITIGATE THIS TYPE OF FAILURE, EACH (B)(4) R2 PAD IS CONFIRMED TO CONNECT PROPERLY TO A MOLEX CONNECTOR DURING MANUFACTURING. ALSO, 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. THE COMPLAINT INVESTIGATION HAS NOT CONCLUSIVELY IDENTIFIED A MANUFACTURING RELATED DEFECT WITH THE R2 MULTIFUNCTION ELECTRODES. 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 1320894-2014-00025 THAT WAS SUBMITTED FOR THE R2 ADAPTOR CABLE UTILIZED IN THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "A NURSE WAS USING OUR R2 PADS TO DEFIBRILLATOR A (B)(6) OLD 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. THE PATIENT ASSOCIATED WITH THIS INCIDENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148863 R2MULTIFUNCTION ELECTRODES, MFE, R2 CONNECTOR R2 MFE / DEFIB PADS LDD CONMED CORPORATION 1308074

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death