BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1920955 · Received December 7, 2010

    Report

    Report Number
    3002158293-2010-01300
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    October 16, 2010
    Report Date
    December 4, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM HAS BEEN CONFIRMED. UPON EVAL, IT WAS DISCOVERED THAT THE CAUSE OF THE SVC CODE 204 WAS DUE TO THE BELT NODE CONNECTOR ((B)(4)) NOT BEING SEATED PROPERLY. THE ROOT CAUSE OF (B)(4) NOT BEING PROPERLY SEATED CANNOT BE POSITIVELY IDENTIFIED. AFTER THE BELT WAS REPAIRED, IT WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTS FROM THE DAMAGED CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE MOTHER OF A (B)(6) MALE PT, CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT A SVC CODE 204. THE PT'S ELECTRODE BELT WAS REPLACED.

    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 17 YR