BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5170080 · Received October 23, 2015

    Report

    Report Number
    3008642652-2015-06701
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    September 24, 2015
    Report Date
    October 21, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (NON-FUNCTIONAL TES) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. UPON EVALUATION, THERE WAS AN OPEN PULSE WIRE IN THE CABLE BETWEEN THE FRONT THERAPY ELECTRODE (TE) AND ECG A. THE CAUSE OF THE TEST FAILURE IS THE OPEN PULSE WIRE. THE ROOT CAUSE OF THE OPEN PULSE WAS EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BELT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT ELECTRODE BELT SN (B)(4) HAS NON-FUNCTIONAL THERAPY ELECTRODES (TES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701445 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1