BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1871229 · Received October 8, 2010

    Report

    Report Number
    3002158293-2010-01047
    Event Type
    Death
    Date Received
    October 8, 2010
    Date of Event
    February 3, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: A ROOT CAUSE ANALYSIS OF MONITOR (B)(4) IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT PASSED AWAY ON (B)(6) 2010. IT IS UNKNOWN IF THE PATIENT WAS WEARING THE DEVICE AT THE TIME OF DEATH. EQUIPMENT WAS RETURNED TO ZOLL ON (B)(6) 2010. UPON RECEIPT, THE MONITOR WOULD NOT POWER ON.

    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 63 YR Death