BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE CARDIAC RECOVERY SYSTEM

    MDR report key: 15320988 · Received August 30, 2022

    Report

    Report Number
    3015185344-2022-00014
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Date of Event
    August 27, 2022
    Report Date
    August 30, 2022
    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 DEVICE WAS EVALUATED AND THE MONITOR PASSED ALL EVALUATION TESTS. RETURNED THERAPY CABLE FAILED SAFETY TEST. THE THERAPY CABLE WAS EVALUATED BY THE KMT ENGINEERING TEAM. KMT ENGINEERING EXAMINED THE THERAPY CABLE AND FOUND THAT MULTIPLE SERVICE REQUIRED FAULTS WERE CAUSED BY INTERMITTENT SHORTS INSIDE THE 15 CONDUCTOR CABLE CAUSED BY ANIMAL BITE DAMAGE. THERAPY CABLE SHOWED NUMEROUS MINOR INCISIONS INTO JACKET OF THE 15 CONDUCTOR BUNDLE, POTENTIALLY CONSISTENT WITH ANIMAL GNAWING/DAMAGE. ANIMAL BITE DAMAGE TO THE CABLE CAUSED INTERMITTENT SHORTS BETWEEN WIRES RESULTING IN THE REPORTED FAILURE.THIS FAILURE WAS RELATED TO A SPECIFIC USE CASE, SO THERE WAS NO IMPACT TO PRODUCT IN INVENTORY OR THE FIELD WHILE INVESTIGATION WAS ONGOING.

    Description of Event or Problem · 0

    PATIENT CALLED IN TO REPORT WITH AN R204F ERROR CODE. CUSTOMER CARE HELPED THE PATIENT REBOOT THE MONITOR BUT THE CODE KEPT COMING BACK. THE ERROR CODE INDICATES A HIGH VOLTAGE MODULE (HVM) NE H-BRIDGE LEAKAGE TEST FAILURE. A REPLACEMENT SYSTEM WAS DELIVERED ON THE SAME DAY AS THE EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144072 ASSURE CARDIAC RECOVERY SYSTEM WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-001 00840241600047

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female