BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE CARDIAC RECOVERY SYSTEM

    MDR report key: 15504126 · Received September 29, 2022

    Report

    Report Number
    3015185344-2022-00018
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    September 25, 2022
    Report Date
    September 28, 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. KMT ENGINEERING EVALUATED THE DEVICE AND FOUND THAT THE RESISTOR SEEMED TO HAVE A MANUFACTURING DEFECT AND THERE WAS SOME EVIDENCE THAT THE REMAINING TRACE OVERHEATED. THIS APPEARS TO BE AN ISOLATED DEFECT IN THE MANUFACTURE OF RESISTOR. THERE IS NO IMPACT TO PRODUCT IN INVENTORY OR THE FIELD SINCE THIS IS NOT A DESIGN OR SYSTEMIC MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    PATIENT REPORTED AN R204E ERROR CODE ON THE WCD MONITOR INDICATING A HIGH VOLTAGE MODULE (HVM) NW H-BRIDGE LEAKAGE TEST FAILURE. THE R204E 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
    1767878 ASSURE CARDIAC RECOVERY SYSTEM WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-001 00840241600047

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male