BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1911494 · Received November 18, 2010

    Report

    Report Number
    3002158293-2010-01234
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    September 19, 2010
    Report Date
    November 17, 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 MONITOR (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (MONITOR IS RESETTING) HAS BEEN CONFIRMED. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A PT SERVICE REP (PSR) CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT ON BEHALF OF A (B)(6) FEMALE PT, TO REPORT THAT THE PT'S MONITOR IS CONSTANTLY RESETTING. THE PT RECEIVED A REPLACEMENT MONITOR.

    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 36 YR