BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3000067 · Received February 4, 2013

    Report

    Report Number
    3008642652-2013-00275
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 25, 2013
    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 (CODE 204) HAS BEEN CONFIRMED. UPON EVALUATION, THERE WAS A SINGLE BENT PIN IN THE ELECTRODE BELT TRUNK CABLE CONNECTOR. THE CAUSE OF THE CODE 204 IS A DISRUPTION IN COMMUNICATION BETWEEN THE ELECTRODE BELT AND THE MONITOR. THE CAUSE OF THE DISRUPTION IN COMMUNICATION IS THE BENT PIN. THE ROOT CAUSE OF THE BENT PIN CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT SERVICE CODE 204. THE PATIENT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45841 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR