BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6705912 · Received July 12, 2017

    Report

    Report Number
    3008642652-2017-05903
    Event Type
    Death
    Date Received
    July 12, 2017
    Date of Event
    June 9, 2017
    Report Date
    July 11, 2017
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    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 SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. DURING THE INCOMING FUNCTIONAL TESTING, A 1 HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, FOLLOWED BY A 5 HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5 HZ SIGNAL, THE DEVICE WAS CONFIRMED TO PROPERLY ENTER INTO A TREATMENT SEQUENCE WHICH INCLUDES A VERIFICATION OF THE TACTILE VIBRATION ALARM, AUDIO MESSAGING, AND SIREN ALARMS, AS WELL AS A TEST OF THE PULSE DELIVERY CIRCUITRY. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER CHARGING OF THE HIGH VOLTAGE CAPACITORS AND PROPER DELIVERY OF FIVE FULL ENERGY 150J BIPHASIC PULSES. THE FUNCTIONAL TESTING CONFIRMED PROPER RESPONSE BUTTON FUNCTIONALITY, ECG ACQUISITION, DETECTION ALGORITHM PERFORMANCE, AND PULSE DELIVERY FUNCTIONALITY. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. DEVICE MANUFACTURE DATE: SN (B)(4): 12/05/2014, SN (B)(4): 08/06/2015.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2017 IN A HOSPITAL WHILE WEARING THE LIFEVEST. IT WAS REPORTED THAT HOSPITAL STAFF WERE WITH THE PATIENT AT THE TIME OF PASSING. REVIEW OF THE DOWNLOAD DATA INDICATES THAT THE PATIENT EXPERIENCED AN ASYSTOLE EVENT, WHICH IS CONSIDERED A NON-LIFE SUSTAINING, NON-TREATABLE RHYTHM. DURING THE ASYSTOLE EVENT, ONE INAPPROPRIATE SHOCK WAS DELIVERED. CPR ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. THE PATIENT PASSED AWAY (B)(6) 2017. THERE IS NO EVIDENCE TO SUGGEST THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH, AS THE PATIENT WAS ALREADY IN A NON-TREATABLE, NON-LIFE SUSTAINING RHYTHM. DURING FOLLOW UP CALL WITH THE PATIENT'S FAMILY, THE PATIENT'S SON STATED THAT THE LIFEVEST DID NOT SAVE HIS FATHER AND IT DID NOT WORK. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH, AS THE PATIENT WAS ALREADY IN A NON-TREATABLE, NON-LIFE SUSTAINING RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488867 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death