BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 23596182 · Received November 19, 2025

    Report

    Report Number
    3015185344-2025-00161
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    June 9, 2025
    Report Date
    June 18, 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- (KP)80014-002, (B)(6), (B)(4). ON SUBSEQUENT REVIEW FIELD REP DETERMINED THAT THE INITIAL KIT # REPORTED WAS INCORRECT. THE CORRECT KIT # WAS IDENTIFIED AS (B)(6). RETURNED THERAPY CABLE PASSED SAFETY BUT FAILED INSPECTION FOR ALERT BUTTON DAMAGE UNRELATED TO THE REPORTED ISSUE. CABLE DAMAGE/BREAKAGE DUE TO FIELD STRESS AND USAGE IS ANTICIPATED AS AN OCCASIONAL OCCURRENCE. WILL CONTINUE TO TREND FOR FUTURE OCCURRENCES.

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY SUBMITTED ON 06/18/2025 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

    PATIENT REPORTED SERVICE ERROR CODE. PATIENT FURTHER STATED NO DAMAGE TO THERAPY CABLE BUT THE SERVICE ERROR CODE IS PERSISTENT. TROUBLESHOOTING UNSUCCESSFUL. THE UNRESOLVABLE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490778 ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-002 00840241600238

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male