BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE CARDIAC RECOVERY SYSTEM

    MDR report key: 15150452 · Received August 2, 2022

    Report

    Report Number
    3015185344-2022-00012
    Event Type
    Malfunction
    Date Received
    August 2, 2022
    Date of Event
    July 29, 2022
    Report Date
    August 2, 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 WEIGHT TEST BUT PASSED BOTH SAFETY AND EIT (PERFORMANCE) TEST. THE THERAPY CABLE WAS EVALUATED BY THE KMT ENGINEERING TEAM. THE KMT ENGINEERING TEAM OBSERVED THERAPY CABLE TO HAVE SIGNIFICANT WEAR THROUGHOUT THE CABLE ASSEMBLY. SIGNS OF SIGNIFICANT LAUNDERING WERE OBSERVED INCLUDING DEGRADATION OF CABLE JACKET MATERIAL AND A WHITE POWDER DEPOSITED THROUGHOUT THE CABLE ASSEMBLY. THE THERAPY CABLE WEAR MAY BE A RESULT OF THE THERAPY CABLE POTENTIALLY BEING LAUNDERED MULTIPLE (MANY) TIMES. THE WHITE POWDER DEPOSITED THROUGHOUT THE CABLE ASSEMBLY IS SOLUBLE IN WATER, POTENTIALLY IT COULD BE EITHER LAUNDRY DETERGENT OR WATER SOFTENER. THIS THERAPY CABLE WAS ASSOCIATED WITH 15 INSTANCES OF EITHER ERROR CODE R2023 (LEADS-OFF LINE ERROR) OR ERROR CODE R2052 (HVM ANTERIOR DEFIBRILLATOR STUCK HIGH TEST FAILURE). THESE ERROR CODES ARE CREATED WHEN THERE IS A RESISTIVE SHORT OF 3,000 OHM TO 1,250,000 OHM BETWEEN THE ANTERIOR OR POSTERIOR DEFIBRILLATOR SIGNAL AND THE SHIELD. THE DEPOSITED POWDER POTENTIALLY COULD HAVE CREATED THIS RESISTIVE SHORT, PARTICULARLY IN THE THERAPY CONNECTOR LOCATION. THIS FAILURE WAS RELATED TO A CASE OF FIELD USE ERROR RESULTING IN CABLE DAMAGE. THERE WAS NO IMPACT TO PRODUCT IN INVENTORY OR THE FIELD WHILE INVESTIGATION WAS ONGOING.

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT THAT THE PATIENT COULD NOT GET THE WCD TO BOOT UP. WHEN CHANGING THE BATTERY THE PATIENT RECEIVED A WRENCH ON THE MONITOR SCREEN AND CORRESPONDING ERROR CODE. THE WCD WOULD THEN GIVE AN AUDIBLE ALERT TO CALL THE HELPLINE AND NEVER COMPLETED THE BOOT UP CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870253 ASSURE CARDIAC RECOVERY SYSTEM WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-001 00840241600047

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female