BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3964457 · Received May 23, 2014

    Report

    Report Number
    3008642652-2014-01581
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CONSTANT GONG ALERTS) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR FAILED INCOMING TESTING. THE CAUSE OF THE CONSTANT GONG ALERTS AND INCOMING TEST FAILURE IS LACK OF DRIVEN GROUND. THE CAUSE OF THE LACK OF DRIVEN GROUND IS AN OPEN R781 RESISTOR. THE ROOT CAUSE OF THE OPEN RESISTOR 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) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CONSTANT GONG ALERTS. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307224 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR