BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE CARDIAC RECOVERY SYSTEM

    MDR report key: 16797154 · Received April 24, 2023

    Report

    Report Number
    3015185344-2023-00042
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    April 21, 2023
    Report Date
    April 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. RETURNED MONITOR PASSED ISL(SAFETY) AND EIT (PERFORMANCE) TESTING. T/C FAILED INSPECTION. KMT ENGINEERING EVALUATED THE RETURNED T/C AND OBSERVED DAMAGED THERAPY CABLE CAUSING SIGNAL INTEGRITY ISSUES LEADING TO MULTIPLE SERVICE ERROR CODES.

    Description of Event or Problem · 0

    PATIENT REPORTED HAVING MULTIPLE ISSUES WITH THEIR SYSTEM THAT HAVE BEEN GOING ON FOR A WHILE NOW. INITIALLY PATIENT STARTED GETTING SERVICE REQUIRED CODES THAT THE PATIENT WAS ABLE TO TROUBLESHOOT BY REBOOTING THE MONITOR. THE PATIENT HAS BEEN GETTING ERROR CODE R203C (HUB DEVICE ERROR).THERE WAS NO SERIOUS INJURY REPORTED. 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
    1273805 ASSURE CARDIAC RECOVERY SYSTEM WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-001 00840241600047

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female