BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4230957 · Received October 15, 2014

    Report

    Report Number
    3008642652-2014-03344
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 24, 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) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. UPON EVALUATION, THE J2 COMPONENT WAS NOT PROPERLY SOLDERED INSIDE THE REAR-1 WIRE 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 DAMAGED BELT CABLE CONNECTOR.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652812 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA