BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3830430 · Received May 14, 2014

    Report

    Report Number
    3008642652-2014-01467
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT MESSAGES, DAMAGED CABLE) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED INCOMING FUNCTIONALITY TESTING. THE TRUNK CABLE SHOWED SIGNS OF PHYSICAL ABUSE. THE CAUSE FOR THE TEST FAILURE WAS ISOLATED TO AN OPEN DRIVEN GROUND WIRE IN THE TRUNK CABLE. THE ROOT CAUSE FOR THE OPEN WIRE COULD NOT POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE OPEN WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT WAS RECEIVING ADJUST BELT MESSAGES AND THAT THE PATIENT'S ELECTRODE BELT HAD DAMAGED CABLES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287914 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR