BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 7222879 · Received January 26, 2018

    Report

    Report Number
    3008642652-2018-10130
    Event Type
    Injury
    Date Received
    January 26, 2018
    Date of Event
    December 16, 2017
    Report Date
    December 29, 2017
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE PATIENT'S DOWNLOADED FLAG FILE CONFIRMED THAT THE DEVICE DECLARED THE TREATABLE ARRHYTHMIA AND RELEASED GEL FROM THE THERAPY ELECTRODES. THE MONITOR RESET AFTER DELIVERING THE PULSE AND THE ECG RECORDINGS OF THE EVENT WERE NOT RECORDED. DUE TO AN SD CARD FAULT, THE PATIENT'S CONTINUOUS ECG RECORDINGS WERE NOT AVAILABLE FOR REVIEW. THE PATIENT'S RHYTHM AT THE TIME OF THE EVENT IS UNKNOWN. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION THE MONITOR PASSED INCOMING FUNCTIONALITY TESTING. A REVIEW OF DOWNLOAD DATA INDICATES THAT THE MONITOR RESET AFTER DELIVERING A PULSE TO A PATIENT IN THE FIELD. THE ROOT CAUSE FOR THE RESET WAS ISOLATED TO NOISE ORIGINATING FROM THE DEFIBRILLATOR PCA HIGH-VOLTAGE CAPACITORS AND PROPAGATING ON THE MAIN BATTERY WIRE ON THE MONITOR C/A BOARD. A DESIGN CHANGE TO ADDRESS THIS CONDITION (PMA SUPPLEMENT P010030/S064) WAS APPROVED BY FDA ON (B)(4) 2015. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. ALL GELS WERE DEPLOYED. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER DELIVERY OF FULL ENERGY 150J BIPHASIC PULSE. THE FUNCTIONAL TESTING CONFIRMED PROPER ECG ACQUISITION AND PULSE DELIVERY FUNCTIONALITY. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT WAS TREATED WHILE AT HOME. THE PATIENT WAS REPORTEDLY CONSCIOUS AND SHOVELING SNOW AT THE TIME OF THE EVENT. THE PATIENT'S PRE-SHOCK AND POST-SHOCK RHYTHMS ARE UNKNOWN. THERE IS NO INDICATION THAT THE PATIENT SUFFERED A SERIOUS INJURY FROM THE TREATMENT EVENT. THE PATIENT FOLLOWED UP WITH HIS PHYSICIAN AFTER THE EVENT AND CONTINUED WEARING THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67160 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other