BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 21356819 · Received February 11, 2025

    Report

    Report Number
    3015185344-2025-00035
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    February 9, 2025
    Report Date
    February 11, 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. RETURNED THERAPY CABLE FAILED INSPECTION. KMT ENGINEERING EVALUATED THE RETURNED THERAPY CABLE AND OBSERVED INTERMITTENT SHORT IN THE HUB CIRCUIT BOARD. THE ISSUE DOES NOT APPEAR TO BE OCCURRING AT A RATE SIGNIFICANT ENOUGH TO TAKE FURTHER ACTION. WILL CONTINUE TO TREND FOR FUTURE OCCURRENCES.

    Description of Event or Problem · 0

    PATIENT CALLED IN TO REPORT SERVICE ERROR CODE MULTIPLE TIMES. PATIENT FURTHER STATED THAT THE MONITOR OFTEN DOES NOT SENSE IT'S PLUGGED IN. THE 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
    836443 ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-002 00840241600238

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male