BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE WEARABLE CARDIOVERTER DEFIBRILLAT

    MDR report key: 23660998 · Received November 26, 2025

    Report

    Report Number
    3015185344-2025-00424
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 26, 2025
    Report Date
    November 26, 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

    DEVICE EVALUATION OF THE ALLEGED MALFUNCTION REQUIRED RETRIEVAL OF THE DEVICE FROM THE PATIENT; RETURN TO THE CONTRACT MANUFACTURER FOR DECONTAMINATION, INSPECTION, AND INITIAL TESTING; FOLLOWED BY SHIPMENT TO THE MANUFACTURER OF RECORD FOR FAILURE INVESTIGATION AND ROOT CAUSE ANALYSIS. ON RETURN AFTER SUBSEQUENT REVIEW IT WAS DETERMINED THAT THE INITIAL WCD SYSTEM # REPORTED WAS INCORRECT. THE CORRECT WCD SYSTEM # WAS IDENTIFIED AS K0032192. 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.

    Description of Event or Problem · 0

    RN FROM EMERGENCY ROOM CALLED TO REPORT THAT THEY HAVE A PATIENT WHO RECEIVED THERAPEUTIC SHOCK. PATIENT ARRIVED TO ED AWAKE, ALERT, ORIENTATED AND NO SYNCOPE EPISODE. THE PATIENT HAD FURTHER REPORTED THAT THEY DID NOT FEEL ANY SHOCK. THE REPORTED INJURY WAS NOT LIFE-THREATENING, DID NOT RESULT IN PERMANENT DAMAGE, OR NECESSITATE MEDICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE. WCD ROLE IN THE SHOCK EVENT IS PENDING ADDITIONAL MEDICAL INFORMATION AND PENDING EVALUATION OF TO-BE-RETURNED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2810315 ASSURE WEARABLE CARDIOVERTER DEFIBRILLAT WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-002 00840241600238

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male