BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 11269305 · Received February 2, 2021

    Report

    Report Number
    3008642652-2021-00890
    Event Type
    Death
    Date Received
    February 2, 2021
    Date of Event
    December 7, 2020
    Report Date
    February 1, 2021
    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 Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED.  THE REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED.  DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE MONITOR, 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 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 EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE ELECTRODE BELT FAILED INCOMING TESTING. THE CAUSE FOR THE FAILURE WAS ISOLATED TO GEL INGRESS THROUGHOUT THE THERAPY ELECTRODES, CREATING A SHORT IN THE THERAPY ELECTRODES, CAUSING THE TEST FAILURE. A ROOT CAUSE INVESTIGATION DETERMINED THAT CONDUCTIVE GEL FROM THE THERAPY ELECTRODES INGRESSED INTO THE THERAPY ELECTRODE ENCLOSURE, CAUSING A SHORT ON THE THERAPY ELECTRODE PCA. THE BELT MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT. DEVICE MANUFACTURER DATE- MONITOR: 11/02/2017, ELECTRODE BELT: 08/12/2015.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT HAD PASSED AWAY ON (B)(6) 2020 AT APPROXIMATELY 09:27:00. THE PATIENT WAS TREATED APPROPRIATELY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT WAS GIVEN CPR AND WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT WAS NOT REQUIRED TO WEAR THE LIFEVEST UPON ARRIVAL AT THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT'S PASSING WAS CARDIAC RELATED. PER CLINICAL REVIEW OF THE AVAILABLE ECG DATA, THE PATIENT EXPERIENCED ONE APPROPRIATE TREATMENT AT 21:04:15 ON (B)(6) 2020. THE PATIENT'S RHYTHM AT THE TIME OF THE APPROPRIATE TREATMENT WAS VENTRICULAR TACHYCARDIA (VT) AT 290 BPM, AND THE POST-SHOCK RHYTHM WAS A SINUS RHYTHM AT 60 BPM. THE PATIENT'S ARRHYTHMIA WAS SUCCESSFULLY CONVERTED TO A SLOWER RHYTHM AS A RESULT OF THE TREATMENT EVENT. A NON-TREATABLE RHYTHM WAS DETECTED AT 21:04:36. AT 21:13:35, THE PATIENT WAS IN BRADYCARDIA AT 40 BPM SLOWING TO BRADYCARDIA AT 20 BPM WITH PVC'S AND CPR/MOTION ARTIFACT. THE RHYTHM THEN DEGRADES TO ASYSTOLE WITH CPR/MOTION ARTIFACT. THE RHYTHM THEN TRANSITIONS TO SINUS RHYTHM AT 60 BPM TRANSITIONING TO SUPRAVENTRICULAR TACHYCARDIA (SVT) AT 150 BPM WITH CPR/MOTION ARTIFACT. THE RHYTHM TRANSITIONS AGAIN TO SINUS TACHYCARDIA AT 140 BPM WITH PVC'S DEGRADING TO VENTRICULAR FIBRILLATION (VF) FOR 12 SECONDS WITH CPR/MOTION ARTIFACT. LASTLY, THE RHYTHM THEN TRANSITIONS TO SINUS TACHYCARDIA AT 110 BPM WITH CPR/MOTION ARTIFACT UNTIL THE ELECTRODE BELT DISCONNECTION AT 22:15:17 ON (B)(6) 2020. THE PATIENT WAS SEEN IN VF FROM 21:33:35 TO 21:33:47. THE TREATABLE ARRYTHMIA OF VF WAS NOT TREATED DUE TO THE OBSTRUCTION OF MOTION ARTIFACT/CPR ARTIFACT AND THE DISCONNECTION OF THE ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160889 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H