BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE CARDIAC RECOVERY SYSTEM

    MDR report key: 15686364 · Received October 27, 2022

    Report

    Report Number
    3015185344-2022-00020
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    October 15, 2022
    Report Date
    October 27, 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. DEVICE EVALUATION CONFIRMS THAT THE THERAPY CABLE FUNCTIONED AS EXPECTED. THERE WAS NO OBSERVED DAMAGE AND ALL GEL WAS FIRED/DEPLOYED DURING THE EVENT. RETURNED THERAPY CABLE FAILED WEIGHT TEST AND SAFETY TEST DUE TO PRE-SHOCK GEL DEPLOYMENT. EVALUATION EVIDENCE INDICATES WCD PERFORMED PER PRESCRIPTION AND INTENDED USE. PATIENT WAS FIT AND TRAINED PRIOR TO INITIAL USE, INCLUDING THE USE OF THE HEART ALERT BUTTON TO CANCEL THE SHOCK. HOWEVER, PATIENT HEARD THE ALERT BUT DID NOT CANCEL THE SHOCK USING THE WCD HEART ALERT BUTTON.

    Description of Event or Problem · 0

    GMR CUSTOMER SUPPORT WAS ALERTED THAT THE PATIENT RECEIVED A THERAPEUTIC SHOCK. GMR CALLED THE PATIENT'S CONTACT NUMBER TWO TIMES BUT WAS NOT ABLE TO REACH HER. GMR CUSTOMER SUPPORT THEN CONTACTED THE PATIENT'S EMERGENCY CONTACT BUT WAS NOT ABLE TO CANCEL THE SHOCK REACH HER. GMR THEN CONTACTED THE PATIENT'S EMERGENCY CONTACT BUT WAS ALSO NOT ABLE TO GET IN TOUCH WITH THE CONTACT PERSON. HOSPITAL PHYSICIAN ASSISTANT REPORTED THE PATIENT RECEIVED A SHOCK FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE (AF/RVR), WHICH IS NOT AN INDICATION FOR WCD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2881055 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