BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4992720 · Received August 11, 2015

    Report

    Report Number
    3008642652-2015-04909
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 27, 2015
    Report Date
    August 6, 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 THERAPY ELECTRODES) WAS CONFIRMED. AS RECEIVED, THE BELT FAILED A THERAPY ELECTRODE RECOGNITION TEST. UPON EVALUATION, THE PULSE WIRE WAS OPEN BETWEEN THE DISTRIBUTION NODE (DN) AND 'ECG B'. THE CAUSE OF THE TEST FAILURE IS THE OPEN WIRE. THE ROOT CAUSE OF THE OPEN WIRE IS EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE OPEN WIRE.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR AN ELECTRODE BELT INDICATING THAT HAD NON-FUNCTIONAL THERAPY ELECTRODES (TES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524453 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1