BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3941379 · Received April 11, 2014

    Report

    Report Number
    3008642652-2014-01109
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 9, 2014
    Report Date
    April 8, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN: (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CONSTANT ADJUST BELT MESSAGES) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WAS INTERMITTENTLY ABLE TO RECOGNIZE THE THERAPY ELECTRODES AND ECG ELECTRODES. THE CAUSE OF THE INTERMITTENT ISSUE IS POOR COMMUNICATION BETWEEN THE MONITOR AND ELECTRODE BELT. THE CAUSE OF THE POOR COMMUNICATION IS A DEFECTIVE BELT CONNECTOR. THE ROOT CAUSE OF THE DEFECTIVE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CONSTANT ADJUST BELT MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220453 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR