BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2142364 · Received May 31, 2011

    Report

    Report Number
    3002158293-2011-00619
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 27, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RED SENSORS ON MONITOR SCREEN) HAS BEEN CONFIRMED. UPON EVALUATION, INTERNAL DAMAGE WAS FOUND TO THE WIRES IN THE C + D ASSEMBLY. THE ROOT CAUSE OF THE DEFECTIVE WIRES CANNOT BE POSITIVELY IDENTIFIED. ONCE THE C + D ASSEMBLY WAS REPLACED, THE BELT WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE INTERNAL DAMAGE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT ALL OF THE SENSORS ARE SHOWING RED ON THE MONITOR SCREEN AND HAS CONFIRMED THAT HIS BELT IS CONNECTED PROPERLY. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR