BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3073073 · Received April 8, 2013

    Report

    Report Number
    3008642652-2013-00950
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 14, 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 Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) HAS BEEN CONFIRMED. UPON EVAL, THE ELECTRODE BELT FAILED A CURRENT AND ECG FALL-OFF TEST. THE CAUSE FOR THE FAILURE WAS ISOLATED TO EXTENSIVE CORROSION ON THE ECG "C" ELECTRODE. COMPONENTS R7, R10, V2, C3, U1, V3, AND C4 WERE CORRODED. THE ROOT CAUSE FOR THE CORROSION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATE ELECTRODE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT WAS RECEIVING A SERVICE CODE 204. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144561 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR