BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE CARDIAC RECOVERY SYSTEM

    MDR report key: 16010951 · Received December 19, 2022

    Report

    Report Number
    3015185344-2022-00033
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    December 16, 2022
    Report Date
    December 19, 2022
    Manufacturer
    KESTRA MEDICAL TECHNOLOGIES, INC.
    Product Code
    MVK
    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 INITIALLY TESTED AND PASSED BOTH ISL (SAFETY) AND EIT (PERFORMANCE) TESTING. KMT ENGINEERING EVALUATED THE RETURNED THERAPY CABLE AND OBSERVED INTERMITTENT SHORT AT THE THERAPY PLUG OVERMOLD. KMT ENGINEERING WAS UNABLE TO FIND EXPOSED CONDUCTOR AND THE ACTUAL FAILURE MODE WAS NOT IDENTIFIED. THE REPORTED ISSUE IS SIMILAR TO A FAILURE INVESTIGATION THAT WAS CAUSED DUE TO THE EXPOSED CONDUCTOR STRANDS. WILL CONTINUE TO TREND FOR FUTURE OCCURRENCES.

    Description of Event or Problem · 0

    PATIENT CALLED IN TO REPORT A SERVICE REQUIRED CODE. THE CODE NUMBER WAS NOT MADE AVAILABLE. THERE IS NO EVENT LOG TO CONFIRM THE ERROR CODE. THERE WAS NO PATIENT INJURY. 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
    2842621 ASSURE CARDIAC RECOVERY SYSTEM WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-001

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male