BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 23596676 · Received November 19, 2025

    Report

    Report Number
    3015185344-2025-00291
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    July 11, 2024
    Report Date
    September 24, 2025
    Manufacturer
    KESTRA MEDICAL TECHNOLOGIES, INC.
    Product Code
    MVK
    UDI-DI
    00840241600238
    PMA / PMN Number
    P200037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SHOCK DELIVERED EVENT WAS IDENTIFIED PAST THE 30-DAY FILE DATE DUE TO DISCOVERY DURING THE REVIEW OF ALL POTENTIAL SHOCK EVENTS FOR THE FINAL WCD POST APPROVAL STUDY REPORT. THE EVENT WAS NOT COMMUNICATED INITIALLY AS AN INAPPROPRIATE SHOCK EVENT AND THEREFORE, WAS NOT FILED WITHIN THE 30-DAY LIMIT. ALSO, THE INITIAL KIT # REPORTED- K0014201. ON RETURN AFTER SUBSEQUENT REVIEW IT WAS DETERMINED THAT THE INITIAL KIT # AND THE EVENT DATE REPORTED WERE INCORRECT. THE CORRECT KIT # WAS IDENTIFIED AS K0009698 AND THE EVENT DATE IS IDENTIFIED AS 07/11/2024. THE RETURNED DEVICE WAS EVALUATED, AND THE MONITOR PASSED ALL EVALUATION TESTS. RETURNED THERAPY CABLE COULD NOT BE TESTED DUE TO SHOCK DELIVERY AND GEL DEPLOYMENT WHICH CONFIRMS THAT THE THERAPY CABLE FUNCTIONED AS EXPECTED. THERE WAS NO OBSERVED DAMAGE, AND ALL GEL WAS DEPLOYED DURING THE EVENT. EVALUATION EVIDENCE INDICATES WCD PERFORMED PER PRESCRIPTION AND INTENDED USE. PATIENT WAS FIT AND TRAINED PRIOR TO INITIAL USE, INCLUDING THE USE OF THE HEART ALERT BUTTON TO CANCEL THE SHOCK. HOWEVER, PATIENT HEARD AND FELT THE ALERT BUT DID NOT CANCEL THE SHOCK USING THE WCD HEART ALERT BUTTON.

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY SUBMITTED ON 09/24/2025 BUT WAS NOT ACK3 ACKNOWLEDGED AS PASSED. IT IS BEING RESUBMITTED WITH THIS STATEMENT ON ADVICE OF THE CDRH MDR TEAM AT OPEQ, OFFICE OF REGULATORY PROGRAMS, DIVISION OF SURVEILLANCE SUPPORT.

    Description of Event or Problem · 0

    THE SHOCK DELIVERED EVENT WAS IDENTIFIED PAST THE 30-DAY FILE DATE DUE TO DISCOVERY DURING THE REVIEW OF ALL POTENTIAL SHOCK EVENTS FOR THE FINAL WCD POST APPROVAL STUDY REPORT. PATIENT'S CAREGIVER REPORTED "CALL 911 NOW, CALL THE ASSURE HELPLINE NOW" ALERT. PATIENT'S CAREGIVER FURTHER CONFIRMED THAT THE PATIENT RECEIVED THERAPEUTIC SHOCK. THE REPORTED INJURY WAS NOT LIFE-THREATENING, DID NOT RESULT IN PERMANENT DAMAGE, OR NECESSITATE MEDICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE. HOWEVER, AN UNDIVERTED SHOCK TO A CONSCIOUS PATIENT COULD RESULT IN SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2629285 ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-002 00840241600238

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male