BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE CARDIAC RECOVERY SYSTEM

    MDR report key: 16993540 · Received May 24, 2023

    Report

    Report Number
    3015185344-2023-00062
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    May 23, 2023
    Report Date
    May 24, 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. KMT ENGINEERING EVALUATED THE RETURNED T/C AND COULD NOT REPRODUCE THE ERROR CODE. THE REPORTED CONDITION WAS NOT ABLE TO BE REPLICATED AND THE IDENTIFIED PRODUCT MALFUNCTION WAS NOT CONFIRMED. WILL CONTINUE TO TREND FOR FUTURE OCCURRENCES.

    Description of Event or Problem · 0

    SERVICE REQUIRED R2013 (MCU SOFTWARE UPDATE FAILURE) ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. 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
    1508799 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