BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3080804 · Received April 12, 2013

    Report

    Report Number
    3008642652-2013-00958
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 21, 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, BENT PINS OR DAMAGED E-BELT CONNECTOR) HAS BEEN CONFIRMED. UPON EVALUATION, THERE WAS AN OPEN WHITE PULSE WIRE IN THE TRUNK CABLE CONNECTOR. THE CAUSE OF THE CHECK BELT MESSAGES IS THE OPEN PULSE WIRE. THE CAUSE FOR THE OPEN PULSE WIRE WAS A DAMAGED TRUNK CABLE CONNECTOR. THE ROOT CAUSE OF THE DAMAGED TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED WIRE. 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. UPON TROUBLESHOOTING A PATIENT SERVICE REPRESENTATIVE NOTICED THE PATIENT'S ELECTRODE BELT TRUNK CABLE CONNECTOR WAS DAMAGED. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158369 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR