BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 23924544 · Received December 30, 2025

    Report

    Report Number
    3015185344-2025-00454
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 25, 2025
    Report Date
    December 30, 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, DATA RETRIEVAL AND INITIAL TESTING; FOLLOWED BY SHIPMENT TO THE MANUFACTURER OF RECORD FOR FAILURE INVESTIGATION AND ROOT CAUSE ANALYSIS. INITIAL KIT # REPORTED - K0032079. ON RETURN AFTER SUBSEQUENT REVIEW IT WAS DETERMINED THAT THE INITIAL KIT # REPORTED WAS INCORRECT. THE CORRECT KIT # WAS IDENTIFIED AS K0034152. THE RETURNED MONITOR PASSED BOTH ISL (SAFETY) AND EIT (PERFORMANCE) TESTING. THE RETURNED DEVICE PASSED ALL FIELD RETURN TESTS AND INSPECTIONS. THE REPORTED CONDITION COULD NOT BE REPLICATED. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. WILL CONTINUE TO TREND FOR FUTURE OCCURRENCES.

    Description of Event or Problem · 0

    PATIENT REPORTED MONITOR REBOOTING OVER AND OVER. TROUBLESHOOTING UNSUCCESSFUL. WCD ROLE IN THE EVENT IS PENDING EVALUATION OF TO-BE-RETURNED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321383 ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-002 00840241600238

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female