BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5077552 · Received September 15, 2015

    Report

    Report Number
    3008642652-2015-05569
    Event Type
    Death
    Date Received
    September 15, 2015
    Date of Event
    August 7, 2015
    Report Date
    September 14, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE MONITOR ECG ACQUISITION CIRCUITRY WAS NON-FUNCTIONAL. THE CAUSE FOR THE FAILURE WAS ISOLATED TO THE COMPUTER/ANALOG (C/A) BOARD. CAPACITOR C655 WAS THERMALLY DAMAGED, AND INVERTING CHARGE PUMP U612 AND LOAD SWITCH U507 WERE NOT PRODUCING ANY OUTPUT. THE ROOT CAUSE FOR THE DEFECTIVE COMPONENTS COULD NOT BE POSITIVELY IDENTIFIED. DEVICE EVALUATION OF ELECTRODE BELT (B)(4) WAS COMPLETED. UPON INVESTIGATION THE TRUNK CABLE AND DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE CABLE WERE PULLED FROM THE STRAIN RELIEF, DAMAGING WIRES IN THE CABLES. THE ROOT CAUSE FOR THE DAMAGED CABLES WAS PHYSICAL ABUSE. PER THE ATTACHED ECG STRIPS, THE LIFEVEST DETECTED A CLEAN ECG SIGNAL DURING THE EVENT AND DELIVERED FOUR FULL ENERGY PULSES. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION CONTRIBUTING TO THE EVENT. THE DAMAGE TO THE MONITOR AND ELECTRODE BELT OCCURRED AFTER DEVICE REMOVAL.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT PASSED AWAY ON (B)(6) 2015 WHILE WEARING THE LIFEVEST. THE PATIENT WAS HOME AT THE TIME OF THE EVENT. THE LIFEVEST DELIVERED FOUR TREATMENTS BETWEEN 04:44:56 AND 04:46:15. THE RHYTHM AT THE TIME OF EACH TREATMENT WAS ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. THE PATIENT REMAINED IN ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY AFTER EACH TREATMENT. OVERSENSING OF SMALL SIGNAL CONTRIBUTED TO THE FALSE DETECTIONS. EMS WAS CALLED TO THE PATIENT'S HOME, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WHERE HE WAS PRONOUNCED. THERE IS NO INDICATION THAT THE TREATMENTS DURING ASYSTOLE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH, AS THE PATIENT WAS ALREADY IN A NON-LIFE-SUSTAINING RHYTHM PRIOR TO TREATMENT DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608014 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death