BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4002195 · Received July 3, 2014

    Report

    Report Number
    3008642652-2014-02084
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 31, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) IS COMPLETE. THE REPORTED PROBLEM (ADJUST BELT/CHECK BELT MESSAGES) WAS CONFIRMED. AS RECEIVED, THE ELECTRODE BELT FAILED INCOMING TESTING. UPON INVESTIGATION, THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) TO REAR THERAPY PAD (TE) WAS PULLED FORM THE STRAIN RELIEF CAUSING A BREAK IN THE REAR PULSE WIRE. THE CAUSE OF THE ADJUST BELT/CHECK BELT MESSAGES WAS THE PULLED DN TO REAR TE CABLE. THE ROOT CAUSE OF THE PULLED DN TO REAR TE CABLE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BELT. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT ADJUST BELT/CHECK BELT MESSAGES. THE PATIENT WAS ISSUES A REPLACEMENT BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392391 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR