BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3983536 · Received June 26, 2014

    Report

    Report Number
    3008642652-2014-01965
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 18, 2014
    Report Date
    June 24, 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 PROBLEMS (DAMAGED ELECTRODE BELT) WAS CONFIRMED. UPON INVESTIGATION THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE (TE) CABLE WAS PULLED FROM THE STRAIN RELIEF. THIS RESULTED IN AN INTERMITTENT CONNECTION BETWEEN THE CABLE AND DN. THE ROOT CAUSE OF THE PULLED CABLES COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER LIFEVEST WAS BROKEN AND THE DEVICE INDICATED TO CALL ZOLL FOR A NEW ELECTRODE BELT. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373963 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR