BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 21103708 · Received January 8, 2025

    Report

    Report Number
    3015185344-2024-00244
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 26, 2024
    Report Date
    January 8, 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 MONITOR FAILED INSPECTION. KMT ENGINEERING EVALUATED THE RETURNED MONITOR AND OBSERVED SHORT IN CIRCUIT BOARD. THE REPORTED ISSUE IS AN ISOLATED FAILURE AND 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 THAT THEIR MONITOR WILL NOT POWER ON WITH EITHER BATTERY INSERTED. PATIENT NOTED THAT WHEN BATTERIES ARE ON THE CHARGER BOTH DISPLAY 100%. THE INABILITY TO POWER UP TO ACTIVE STATUS 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
    1236122 ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-002 00840241600238

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female