BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 23596410 · Received November 19, 2025

    Report

    Report Number
    3015185344-2025-00220
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 16, 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

    THIS FILE WAS ORIGINALLY SUBMITTED ON 07/16/2025 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.

    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. 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 FELT THE ALERT BUT DID NOT CANCEL THE SHOCK USING THE WCD HEART ALERT BUTTON.

    Description of Event or Problem · 0

    SHOCK DELIVERED NOTIFICATION WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. PATIENT WAS ON TREADMILL AT THE GYM, HAD HEADPHONES ON SO DIDN'T HEAR THE ALERT GOING OFF AND WAS SHOCKED. PATIENT REFUSED EMR TWICE AND IS CONSCIOUS AND COHERENT. 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
    2490781 ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-002 00840241600238

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male