BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2953971 · Received January 15, 2013

    Report

    Report Number
    3008642652-2013-00114
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    March 11, 2012
    Report Date
    January 10, 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 (SERVICE CODE 204) HAS BEEN CONFIRMED. UPON EVALUATION, THERE WAS A BENT PIN IN THE ELECTRODE BELT TRUNK CABLE CONNECTOR. THE CAUSE FOR THE CODE 204 IS A DISRUPTION IN COMMUNICATION BETWEEN THE MONITOR AND ELECTRODE BELT. THE CAUSE FOR THE DISRUPTION IN COMMUNICATION IS THE BENT PIN IN THE ELECTRODE BELT TRUNK CABLE CONNECTOR. THE ROOT CAUSE FOR THE BENT PIN CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21961 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR