BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6182767 · Received December 16, 2016

    Report

    Report Number
    3008642652-2016-09302
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 13, 2016
    Report Date
    December 16, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) HAS BEEN CONFIRMED. AS RECEIVED, THE ELECTRODE BELT FAILED INCOMING FUNCTIONALITY TESTING. THE CAUSE FOR THE SERVICE CODE 204 AND TEST FAILURE WAS ISOLATED TO AN OPEN YELLOW (PGND) WIRE IN THE TRUNK CABLE. THE ROOT CAUSE FOR THE OPEN WIRE WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) AND REPORTED THAT A PATIENT HAD RECEIVED A SERVICE CODE 204; "BELT/MONITOR UNUSABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833386 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1