BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2800151 · Received October 12, 2012

    Report

    Report Number
    3008642652-2012-02707
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 30, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 WHITE (DRIVEN GROUND) AND YELLOW (PGND) WIRES WERE OPEN IN THE TRUNK CABLE, CAUSING THE SERVICE CODE 204. THE ROOT CAUSE FOR THE OPEN WIRES COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE PLACED ON THE TRUNK CABLE. NO ADVERSE EVENT RESULTED FROM THE BROKEN WIRES. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE HOME HEALTHCARE 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
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR