BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE CARDIAC RECOVERY SYSTEM

    MDR report key: 16471158 · Received March 2, 2023

    Report

    Report Number
    3015185344-2023-00025
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    March 1, 2023
    Report Date
    March 2, 2023
    Manufacturer
    KESTRA MEDICAL TECHNOLOGIES, INC.
    Product Code
    MVK
    UDI-DI
    00840241600047
    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 AND INITIAL TESTING; FOLLOWED BY SHIPMENT TO THE MANUFACTURER OF RECORD FOR FAILURE INVESTIGATION AND ROOT CAUSE ANALYSIS. THE RETURNED MONITOR WAS TESTED AND PASSED BOTH ISL (SAFETY) AND EIT (PERFORMANCE) TESTING . THERAPY CABLE PASSED WEIGHT, SAFETY BUT FAILED EIT. KMT ENGINEERING EVALUATED THE RETURNED THERAPY CABLE AND OBSERVED THAT THE MICROCONTROLLER'S USB CIRCUIT IS NOT FULLY FUNCTIONING CAUSING THE REPORTED SERVICE ERROR CODE.

    Description of Event or Problem · 0

    PATIENT'S CAREGIVER CALLED IN TO REPORT THAT THE PATIENT IS GETTING R2013(MCU SOFTWARE UPDATE ERROR) ERROR CODE. THERE WAS NO PATIENT INJURY. HOWEVER, 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
    453696 ASSURE CARDIAC RECOVERY SYSTEM WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-001 00840241600047

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male