BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4230959 · Received October 15, 2014

    Report

    Report Number
    3008642652-2014-03339
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 14, 2014
    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) HS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. UPON EVALUATION, THE J2 COMPONENT WAS NOT PROPERLY SOLDERED INSIDE THE FRONT THERAPY ELECTRODE. THE CAUSE OF THE CHECK THERAPY PAD MESSAGES IS THE IMPROPERLY SOLDERED J2 COMPONENT. THE ROOT CAUSE OF THE IMPROPER SOLDER IS A MANUFACTURING ERROR. A CORRECTIVE ACTION WAS INITIATED. NO ADVERSE EVENT RESULTED FROM THE DAMAGE BELT CABLE CONNECT.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) TO REPORT THAT THE THERAPY ELECTRODES (TE) WERE NON-FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652623 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA