BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4812479 · Received May 29, 2015

    Report

    Report Number
    3008642652-2015-03474
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 26, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: 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 TRUNK CABLE. THE CAUSE OF THE TEST FAILURE IS THE OPEN PULSE WIRE. THE ROOT CAUSE OF THE OPEN PULSE WIRE 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
    349356 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA