BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10410877 · Received August 14, 2020

    Report

    Report Number
    3008642652-2017-00114
    Event Type
    Death
    Date Received
    August 14, 2020
    Date of Event
    November 23, 2016
    Report Date
    January 5, 2017
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED THE MONITOR WAS UNABLE TO RECOGNIZE SIGNALS FROM ALL ECGS AND THERAPY ELECTRODES FROM A TEST BELT. UPON INVESTIGATION THE MONITOR WAS NOT PROPERLY PRODUCING A DRIVEN GROUND SIGNAL. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN OPEN R781 DRIVEN GROUND RESISTOR ON THE COMPUTER/ANALOG BOARD. THE DAMAGE TO THE RESISTOR WAS CAUSED BY THE EXTERNAL DEFIBRILLATION. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. 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 A 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

    8/14/2020: RESUBMITTING THIS MDR AS PART OF AN INTERNAL AUDIT WHICH INDICATED THAT ACKNOWLEDGEMENT 1 AND 2 WERE RECEIVED, HOWEVER DUE TO A TYPOGRAPHICAL ERROR IN THE REPORT NUMBER, WHICH DOCUMENTED THIS AS A 2016 REPORT WHEN IT WAS ACTUALLY A 2017 REPORT, THE MDR SUBMISSION FAILED AS A DUPLICATE REPORT. THE REPORT NUMBER WAS CORRECTED, AND IS BEING RESUBMITTED. A DISTRIBUTOR CONTACTED ZOLL TO REPORT A PATIENT DEATH. IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2016 WHILE WEARING THE LIFEVEST. THERE ARE NO ADDITIONAL DETAILS SURROUNDING THE EVENT. REVIEW OF THE DOWNLOADED DATA INDICATES THAT THE DEVICE PROPERLY DETECTED AND ALARMED FOR VENTRICULAR FIBRILLATION AT 01:16:35; HOWEVER, THE LIFEVEST FELL OUT OF DETECTION DUE TO VARYING AMPLITUDE, MOTION ARTIFACT, AND TACTILE ARTIFACT BEFORE A TREATMENT COULD BE DELIVERED. THERE WERE TWO EXTERNAL DEFIBRILLATIONS BETWEEN 01:45 AND 01:55. THE PRE-SHOCK RHYTHM FOR BOTH TREATMENTS WAS VENTRICULAR FIBRILLATION. THE POST-SHOCK RHYTHM FOR THE FIRST DEFIBRILLATION WAS BRADYCARDIA. THE SECOND POST-SHOCK RHYTHM WAS SVT AT 170 BPM. ASYSTOLE WITH MOTION ARTIFACT AND INTERMITTENT CARDIAC ACTIVITY IS SEEN BETWEEN 02:25:34 AND 03:44:29. ASYSTOLE IS CONSIDERED A NON-SHOCKABLE RHYTHM. THERE ARE NO ALLEGED DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875221 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death