BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10121586 · Received June 4, 2020

    Report

    Report Number
    3008642652-2020-04994
    Event Type
    Death
    Date Received
    June 4, 2020
    Date of Event
    April 22, 2020
    Report Date
    June 4, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ELECTRODE BELT SN (B)(6) AND MONITOR SN (B)(6) WERE RETURNED TO THE MANUFACTURER AND THE EVALUATION IS CURRENTLY UNDERWAY. DEVICE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE PATIENT'S PASSING. MANUFACTURE DATES: MONITOR: 3/25/2020, ELECTRODE BELT: 6/18/2012. DEVICE EVALUATION OF MONITOR SN (B)(6) HAS BEEN COMPLETED. 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. IT WAS REPORTED THAT THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA AMBULANCE FOLLOWING THE EVENT. PER THE EVENT ANALYISIS, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION CONTRIBUTING TO THE REPORTED PROBLEM. THE ROOT CAUSE FOR THE OPEN RESISTOR COULD NOT BE POSITIVELY IDENTIFIED. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(6) HAS BEEN COMPLETED. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, FOLLOWED BY A 5HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5HZ 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.

    Description of Event or Problem · 0

    A DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A GERMAN PATIENT PASSED AWAY ON (B)(6) 2020 WHILE WEARING THE LIFEVEST. IT WAS REPORTED THAT THE PATIENT COLLAPSED ON THE STREET PRIOR TO PASSING. REVIEW OF THE PAITENT'S DOWNLOAD DATA REVEALED THAT PRIOR TO PASSING, THE PATIENT RECEIVED AN APPROPRIATE TREATMENT FROM THE LIFEVEST. AT 9:29:59 AM, THE PATIENT WAS TREATED BY THE LIFEVEST. THE PAITENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS VENTRICULAR TACHYCARDIA (VT) AT 170 BPM AND THE POST-SHOCK RHYTHM WAS ASYSTOLE. POST-SHOCK ASYSTOLE IS A KNOWN AND POTENTIALLY ADVERSE OUTCOME OF DEFIBRILLATION THERAPY. THE PATIENT WAS REPORTEDLY TAKEN TO THE HOSPITAL VIA AMBULANCE, WHERE HE PASSED AWAY. DURING THE INVESTIGATION OF THE PATIENT'S MONITOR FOLLOWING THE EVENT, A REPORTABLE MALFUNCTION WAS FOUND.

    Additional Manufacturer Narrative · 1

    ELECTRODE BELT SN (B)(4) AND MONITOR SN (B)(4) WERE RETURNED TO THE MANUFACTURER AND THE EVALUATION IS CURRENTLY UNDERWAY. DEVICE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE PATIENT'S PASSING. MANUFACTURE DATES: MONITOR: 03/25/2020, ELECTRODE BELT: 06/18/2012.

    Description of Event or Problem · 1

    A DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A (B)(6) PATIENT PASSED AWAY ON (B)(6) 2020 WHILE WEARING THE LIFEVEST. IT WAS REPORTED THAT THE PATIENT COLLAPSED ON THE STREET PRIOR TO PASSING. REVIEW OF THE PATIENT'S DOWNLOAD DATA REVEALED THAT PRIOR TO PASSING, THE PATIENT RECEIVED AN APPROPRIATE TREATMENT FROM THE LIFEVEST. AT 9:29:59 AM, THE PATIENT WAS TREATED BY THE LIFEVEST. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS VENTRICULAR TACHYCARDIA (VT) AT 170 BPM AND THE POST-SHOCK RHYTHM WAS ASYSTOLE. POST-SHOCK ASYSTOLE IS A KNOWN AND POTENTIALLY ADVERSE OUTCOME OF DEFIBRILLATION THERAPY. THE PATIENT WAS REPORTEDLY TAKEN TO THE HOSPITAL VIA AMBULANCE, WHERE HE PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581214 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death| O