BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3080779 · Received April 12, 2013

    Report

    Report Number
    3008642652-2013-00952
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 3, 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 (CHECK BELT MESSAGES) WAS CONFIRMED. UPON EVALUATION, THE TRUNK CABLE CONNECTOR WAS CRACKED. THE CAUSE OF THE CHECK BELT MESSAGES IS DAMAGE TO THE BROWN (-5V) AND BLACK (MAIN BATT) WIRES INSIDE THE TRUNK CABLE. THE CAUSE OF THE DAMAGE IS DAMAGED CONNECTOR. THE ROOT CAUSE OF THE DAMAGED CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED TRUNK CABLE AND WIRES. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158020 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR