BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD4000 SYSTEM

    MDR report key: 2974582 · Received January 29, 2013

    Report

    Report Number
    3008642652-2013-00245
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 22, 2013
    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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 204) HAS BEEN CONFIRMED. UPON EVALUATION, THE BELT CONNECTOR CAUSED AN INTERMITTENT FALLOFF WHEN MANIPULATED. THE ROOT CAUSE FOR THE INTERMITTENT SIGNAL AS A DEFECTIVE BELT CONNECTOR COULD NOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE AT THE BELT CONNECTOR WHILE THE ELECTRODE BELT WAS ATTACHED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR BELT CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A SERVICE CODE 204. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39848 LIFEVEST WCD4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR