BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2821939 · Received September 28, 2012

    Report

    Report Number
    3008642652-2012-02518
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 24, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVALUATED OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CONSTANT 'GONGING') HAS BEEN CONFIRMED. UPON EVAL, THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) AND THE ECG ELECTRODE C AND D ASSEMBLY WAS PULLED FROM THE DN, THERE WERE UNATTACHED PULSE WIRES INSIDE OF ECG ELECTRODE A AND THE J704 CONNECTOR WAS DAMAGED ON THE PCA BOARD. THE CAUSE OF THE CONSTANT GONGING IS THE DAMAGE TO THE ELECTRODE BELT. THE EXACT SOURCE OF THE GONGING COULD NOT BE POSITIVELY IDENTIFIED. THE ROOT CAUSE OF THE DAMAGED BELT CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT'S NURSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S DEVICE WAS 'GONGING' ALL NIGHT. SUPPORT REVIEWED THE PT'S DOWNLOAD AND NOTED HIGHFALL-OFF AND DUAL-LEAD NOISE. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    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 58 YR