BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE CARDIAC RECOVERY SYSTEM

    MDR report key: 17146443 · Received June 16, 2023

    Report

    Report Number
    3015185344-2023-00079
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    June 15, 2023
    Report Date
    June 16, 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 SAFETY AND PERFORMANCE TESTING. RETURNED T/C PASSED WEIGHT, SAFETY, AND EIT. RETURNED MONITOR PASSED ISL AND FAILED EIT. KMT ENGINEERING EVALUATED THE RETURNED MONITOR AND OBSERVED A VISIBLE GAP BETWEEN SCREW AND PCBA. THIS MATCHES WITH THE FAILURE MODE OF THE LOGGED FAILURE DATA . THE LOOSENESS COULD CAUSE THE INTERMITTENT FAILURE. RESOLUTION OF TORQUE NOT BEING FULLY FASTENED HAS BEEN IMPLEMENTED AT SUPPLIER.

    Description of Event or Problem · 0

    PATIENT CALLED IN TO REPORT SERVICE ERROR CODE - R204E. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. 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
    679478 ASSURE CARDIAC RECOVERY SYSTEM WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-001 00840241600047

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male