BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823780 · Received May 2, 2014

    Report

    Report Number
    3008642652-2014-01343
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) IS STILL UNDERWAY. THE REPORTED PROBLEM (CHECK BELT MESSAGES) WAS CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. THE CAUSE OF THE CHECK BELT MESSAGE AND INCOMING TEST FAILURE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVALUATION. NO ADVERSE EVENT RESULTED DEFECTIVE BELT. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT'S NURSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CONSTANT CHECK BELT ALARMS. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264080 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR