BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2860453 · Received November 5, 2012

    Report

    Report Number
    3008642652-2012-02900
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADD GEL) HAS BEEN CONFIRMED. UPON EVALUATION, THE CABLE CONNECTING THE REAR THERAPY ELECTRODE (TE) AND THE DISTRIBUTION NODE (DN) WAS PULLED FROM THE DN, EXPOSING WIRES. THE CAUSE FOR THE REPORTED ADD GEL MESSAGES IS THE DAMAGED ABLE AND WIRES. THE ROOT CAUSE OF THE DAMAGED CABLE AND WIRES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE AND WIRES. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT 'ADD GEL' MESSAGES WHEN NO GEL WAS DEPLOYED. UPON SERVICING OF THE BELT, A REPORTABLE EVENT WAS DISCOVERED. THE ELECTRODE BELT HAD A DAMAGE CABLE. THE PATIENT 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 68 YR