BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE CARDIAC RECOVERY SYSTEM

    MDR report key: 16057122 · Received December 27, 2022

    Report

    Report Number
    3015185344-2022-00037
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    December 24, 2022
    Report Date
    December 27, 2022
    Manufacturer
    KESTRA MEDICAL TECHNOLOGIES, INC.
    Product Code
    MVK
    PMA / PMN Number
    P200037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE INVOLVED IN THE ADVERSE EVENT WAS NOT RETURNED FOR TESTING DESPITE REQUESTS BY MANUFACTURER. DUE TO UNAVAILABILITY OF THE WCD SYSTEM KIT, KMT WAS UNABLE TO EVALUATE THE DEVICE AND DETERMINE ITS ROOT CAUSE. WILL CONTINUE TO MONITOR AND TRACK THE WCD SYSTEM FOR INVESTIGATION AND PERFORM DEVICE EVALUATION SHOULD IT BE LOCATED AND RECOVERED IN THE FUTURE.

    Description of Event or Problem · 0

    PATIENT'S CAREGIVER REPORTED THE TIP ON THE BATTERY/MONITOR IS BROKEN AND WAS UNSURE OF HOW IT BROKE. PATIENT AND CAREGIVER TRIED TO POWER UP THE WCD SYSTEM WITH BOTH THE BATTERIES BUT WAS UNABLE TO USE THE WCD. THE USE ERROR INVOLVES FAILURE TO OPERATE THE DEVICE ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS OR RECOGNIZED BEST PRACTICE. THERE WAS NO PATIENT INJURY. HOWEVER, IF IT WERE TO RECUR IT COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2590900 ASSURE CARDIAC RECOVERY SYSTEM WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-001

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female