BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 16442538 · Received February 27, 2023

    Report

    Report Number
    3008642652-2023-01821
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 16, 2023
    Report Date
    February 27, 2023
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MONITOR AND ELECTRODE BELT HAVE NOT BEEN RETURNED FOR EVALUATION. BASED ON THE DATA AVAILABLE AT THIS TIME, THERE IS NO INDICATION OF A DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO THE INAPPROPRIATE TREATMENT. 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 G960083 (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 · 0

    THE PATIENT WAS INAPPROPRIATELY TREATED 4 TIMES BY THE LIFEVEST. THE PATIENT WAS REPORTEDLY CONSCIOUS AT THE TIME OF THE EVENT. MULTIPLE COUNTING OF THE ECG SIGNAL AND MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE PRESSED. NO INJURY WAS REPORTED FROM THE TREATMENT. THE PATIENT DID NOT SEEK MEDICAL ATTENTION. THE PATIENT CONTINUED TO USE THE LIFEVEST. NO DEFICIENCIES WERE ALLEGED AGAINST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800301 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown