BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIAB EURODEFIPADS

    MDR report key: 15634186 · Received October 19, 2022

    Report

    Report Number
    3003072803-2022-00001
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    October 7, 2022
    Report Date
    October 17, 2022
    Manufacturer
    FIAB S.P.A.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    NOTES FROM MANUFACTURER TO FDA: 1. THE EVENT OCCURRED IN ITALY (NOT IN US); 2. THE PRODUCT REPORTED INVOLVED IN THE INCIDENT - MODEL F7952 - IS IDENTICAL TO THE PRODUCT CLEARED FOR THE MARKETING IN US UNDER THE 510(K) K103783 AND HAVING MODEL (B)(6).; 3. ADDITIONAL INVESTIGATION, IN THE LACK OF THE SAMPLE TO BE ANALYSED (DISCARDED BY THE USER) WILL INVOLVE INTERVIEW TO HEALTHCARE PERSONNEL, DHR REVIEW, PMS DATA REVIEW; 4. A FOLLOWUP / FINAL REPORT WILL FOLLOW AS SOON AS THE INVESTIGATION IS COMPLETED . (B)(6) 2023 FOLLOW UP: AS ANTICIPATED, THE REPORTING STRUCTURE WAS CONTACTED AND AN INSPECTION WAS ORGANIZED; IN RESPONSE TO THE REQUEST FOR CLARIFICATION, THE OPERATOR WHO DETECTED THE EPISODE, AN EXPERT NURSE FROM RESCUE SERVICE, PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: 1) THE PLATES WERE FIRST APPLIED TO THE PATIENT AND SUBSEQUENTLY CONNECTED TO THE DEFIBRILLATOR CABLE. THE PLATES WERE THEN CONNECTED BUT NOT RECOGNIZED BY THE DEVICE WHICH SENT THE 'CONNECT PLATES' SIGNAL. 2) THE DEVICE WAS SWITCHED OFF AND ON AGAIN, REPEATING THE CABLE CONNECTIONS, 3 TIMES. SUBSEQUENTLY THE PLATES WERE REMOVED AND THE ORIGINAL PLATES WERE APPLIED WHICH WERE CORRECTLY RECOGNIZED BY THE INSTRUMENT AND ALLOWED THE DEFIBRILLATION OF THE PATIENT. 3) IT IS NOT POSSIBLE - AND IS THEREFORE EXCLUDED - THE POSSIBILITY OF IMPROPER CONNECTION (FOR EXAMPLE 'UPSIDE DOWN') OF THE PLATE CONNECTOR. THE OPERATOR'S DETAILS RELATED TO THE PROCEDURE CONFIRM THAT THE IFU OF THE LIFEPACK 15 MONITOR DEFIBRILLATOR HAVE BEEN FOLLOWED. SINCE THE SAMPLE OF PLATES INVOLVED WAS NOT AVAILABLE (THROWN AWAY AFTER USE), THE MONITOR DEFIBRILLATOR LIFEPACK 15 USED DURING THE PROCEDURE IN QUESTION WAS SUBSEQUENTLY TESTED BY THE HEALTHCARE FACILITY WITH OTHER FIAB PLATES OF THE SAME LOT 22DF1826 AND NO PLATE RECOGNITION PROBLEM WAS DETECTED. IN THE LIGHT OF WHAT HAS BEEN REPORTED AND THE FACT THAT IT WAS NOT POSSIBLE TO CARRY OUT A TECHNICAL INVESTIGATION ON THE PLATES OBJECT OF THE REPORT SINCE THEY WERE THROWN AWAY, IT IS NOT POSSIBLE TO ESTABLISH THE CAUSE OF THE REPORTED PROBLEM, EXCEPT BY MAKING UNVERIFIABLE HYPOTHESIS. THE DATA COMING FROM FIAB POST MARKETING SURVEILLANCE INDICATE THAT IT IS AN ISOLATED CASE THAT CANNOT BE GENERALIZED EITHER TO THE PRODUCT AND/OR ITS COMPONENTS OR TO THE SPECIFIC LOT 22DF1826: THIS EVENT IS IN FACT THE FIRST REPORTED CASE OF A PLATE WHICH IS NOT FULLY RECOGNIZED BY THE DEFIBRILLATOR. THE MOST PLAUSIBLE CAUSE SEEMS TO BE THE INCORRECT INSERTION OF THE PLATES INSIDE THE DEFIBRILLATOR OR DAMAGE TO THE PLATES CONNECTOR WHICH MADE IMPOSSIBLE A CONTACT BETWEEN THE ELECTRICAL TERMINALS OF THE RESPECTIVE CONNECTORS .

    Additional Manufacturer Narrative · 0

    NOTES FROM MANUFACTURER TO FDA: 1. THE EVENT OCCURRED IN ITALY (NOT IN US). 2. THE PRODUCT REPORTED INVOLVED IN THE INCIDENT - MODEL: F7952 - IS IDENTICAL TO THE PRODUCT CLEARED FOR THE MARKETING IN US UNDER THE 510(K): K103783 AND HAVING MODEL: NR. U7952. 3. ADDITIONAL INVESTIGATION, IN THE LACK OF THE SAMPLE TO BE ANALYSED (DISCARDED BY THE USER) WILL INVOLVE INTERVIEW TO HEALTHCARE PERSONNEL, DHR REVIEW, PMS DATA REVIEW. 4. A FOLLOWUP / FINAL REPORT WILL FOLLOW AS SOON AS THE INVESTIGATION IS COMPLETED. (EXPECTED DEADLINE 11/30/2022).

    Description of Event or Problem · 0

    FIAB DISPOSABLE MULTIFUNCTION ELECTRODES FOR DEFIBRILLATION (MODEL F7952) WERE NOT RECOGNIZED WHEN CONNECTED TO THE MONITOR / DEFIBRILLATOR LIFEPAK 15, THE MONITOR SHOWED THE ERROR MESSAGE "CONNECT ELECTRODES".

    Description of Event or Problem · 0

    FIAB DISPOSABLE MULTIFUNCTION ELECTRODES FOR DEFIBRILLATION (MODEL: F7952) WERE NOT RECOGNIZED WHEN CONNECTED TO THE MONITOR / DEFIBRILLATOR LIFEPAK 15, THE MONITOR SHOWED THE ERROR MESSAGE "CONNECT ELECTRODES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2945743 FIAB EURODEFIPADS DISPOSABLE MULTIFUNCTION ELECTRODES LDD FIAB S.P.A. F7952 22DF1826

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Required Intervention MONITOR / DEFIBRILLATOR LIFEPAK 15| MONITOR / DEFIBRILLATOR LIFEPAK 15