BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 9597120 · Received January 16, 2020

    Report

    Report Number
    3008642652-2020-00359
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    December 13, 2019
    Report Date
    January 14, 2020
    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

    EXPLANATION: THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT. DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED AT THE DISTRIBUTOR. 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) WAS COMPLETED. THE TRUNK CABLE CONNECTOR WAS COSMETICALLY DAMAGED, BUT THE CONNECTOR WAS STILL ABLE TO SECURELY LATCH TO A MONITOR. THE ELECTRODE BELT'S ECG ACQUISITION AND PULSE DELIVERY CIRCUITRY WAS FULLY FUNCTIONAL. PATIENT PROTECTION WAS NOT AFFECTED. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR WAS PHYSICAL ABUSE. MANUFACTURE DATE: MONITOR - (B)(4) - 06/03/2014, BELT - (B)(4) - 101/22/2014. THE INVESTIGATION INTO THE EVENT CONCLUDES THAT THERE WAS NO DEVICE MALFUNCTION. A CAUSE AND EFFECT ANALYSIS WAS CONDUCTED USING ALL OF THE AVAILABLE INFORMATION WHICH INCLUDES THE INCIDENT REPORT, DEVICE EVALUATION, SOFTWARE FLAG FILES, AND ECG STRIPS. THE PRIMARY CAUSE OF THE INAPPROPRIATE SHOCK WAS LACK OF RESPONSE BUTTON USE BY THE PATIENT DURING THE FALSE DETECTION. . IT WAS REPORTED THAT THE PATIENT' S DOCTOR AND NURSE INSTRUCTED THEM NOT TO PRESS THE RESPONSE BUTTONS TO DELAY TREATMENT. THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE RAPID RATE SATISFIED THE RATE DETECTOR OF THE DETECTION ALGORITHM. INAPPROPRIATE DEFIBRILLATIONS ARE AN ANTICIPATED RISK ASSOCIATED WITH THE USE OF THE LIFEVEST. PATIENTS ARE INSTRUCTED THROUGH ALARMS, VOICE MESSAGES, IFU, AND TRAINING TO PRESS THE RESPONSE BUTTONS TO PREVENT AN INAPPROPRIATE DEFIBRILLATION. THE CURRENT COMMERCIAL INAPPROPRIATE DEFIBRILLATION RATE IS CONSISTENT WITH THE OBSERVED RATE DURING THE PIVOTAL CLINICAL TRIAL (B)(4) (0.69% PER PATIENT-MONTH WITH 90% CONFIDENCE). A SUMMARY OF THE SAFETY AND EFFECTIVENESS DATA (SSED), INCLUDING THE INAPPROPRIATE DEFIBRILLATION SAFETY OBJECTIVE SUPPORTING FDA'S APPROVAL OF THE LIFEVEST, CAN BE FOUND AT HTTP://WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF/P010030B.PDF. THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH IEC 60601-2-4 PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT CONSISTING OF ONE SHOCK. IT WAS REPORTED THAT THE PATIENT WAS CONSCIOUS. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. IT WAS REPORTED THAT THE PATIENT' S DOCTOR AND NURSE INSTRUCTED THEM NOT TO PRESS THE RESPONSE BUTTONS. ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) CONTRIBUTED TO THE FALSE DETECTION. THE RAPID RATE SATISFIED THE RATE DETECTOR OF THE DETECTION ALGORITHM. THE PATIENT RECEIVED MEDICAL ATTENTION AT THE HOSPITAL EMERGENCY ROOM AND CONTINUES TO WEAR THE LIFEVEST. THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61085 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O