BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2632673 · Received June 22, 2012

    Report

    Report Number
    3008642652-2012-01551
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    June 6, 2012
    Report Date
    June 19, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 (CHECK BELT MESSAGES/DAMAGED CABLE) HAS BEEN CONFIRMED. UPON EVALUATION, THE CABLES CONNECTING THE DISTRIBUTION NODE TO ECG ELECTRODE B, ECG ELECTRODE B TO ECG ELECTRODE A, AND ECG ELECTRODE C TO ECG ELECTRODE D WERE ALL DAMAGED. IN ADDITION, CONTAMINATION WAS FOUND INSIDE OF THE FRONT THERAPY ELECTRODE (TE). THE CAUSE OF THE CHECK BELT MESSAGES IS THE EXTENSIVE DAMAGE TO THE CABLES AND THE CONTAMINATION OF THE FRONT TE. THE ROOT CAUSE OF THE DAMAGED CABLES AND CONTAMINATION OF THE FRONT TE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLES AND CONTAMINATED TE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT'S MOTHER CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CHECK BELT MESSAGES AND A CUT IN ONE OF THE ELECTRODE BELT CABLES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR