BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3080832 · Received April 12, 2013

    Report

    Report Number
    3008642652-2013-00987
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ZOLL 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 / DAMAGED CABLE) WAS CONFIRMED. UPON EVALUATION, THE TRUNK CABLE CONNECTOR WAS CRACKED AND ORANGE (+5V) WIRE WAS OPEN. THE CAUSE OF THE CODE 204 IS THE OPEN ORANGE WIRE. THE CAUSE OF THE OPEN WIRE IS CRACKED TRUNK CABLE CONNECTOR. THE ROOT CAUSE OF THE CRACKED TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED TRUNK CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A SERVICE CODE 204. WHEN A PT SERVICE REPRESENTATIVE (PSR) VISITED THE PT TO EXCHANGE HER EQUIPMENT, THE PSR REPORTED DAMAGE TO THE ELECTRODE BELT TRUNK CABLE. THE PT WAS ISSUED A REPLACEMENT BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158632 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR