BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1071793 · Received July 7, 2008

    Report

    Report Number
    3002158293-2008-00308
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT HAS BEEN COMPLETED. THE ELECTRODE BELT WAS FOUND TO HAVE AN OPEN CONNECTION IN THE DISTRIBUTION NODE. THE WHITE WIRE, WHICH CARRIES THE SIGNAL FOR THE RIGHT ELECTRODE, WAS OFF OF ITS PAD. THE ENTIRE CABLE WAS STRAINED. THE DISTRIBUTION NODE WAS REPAIRED AND THE ELECTRODE BELT WAS TESTED. BASELINE EVALUATION WAS PERFORMED AND THE CARDIAC SIGNAL NOW APPEARS NORMAL. THE ELECTRODE BELT WAS RETURNED TO STOCK. THE ROOT CAUSE OF THIS OPEN CONNECTION IS UNKNOWN BUT IS LIKELY DUE TO STRAIN PLACED ON THE CABLE DURING PATIENT USE. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A FEMALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT SHE WAS GETTING "ADJUST BELT" MESSAGES. SHE STATED THAT SHE HAD JUST CHANGED THE GARMENT AND ADJUSTED THE ELECTRODE BELT. SUPPORT HAD THE PATIENT DOWNLOAD AND THE DOWNLOAD REVEALED RIGHT FALLOFF. SUPPORT TRIED TO SEND A PATIENT SERVICE REPRESENTATIVE (PSR) TO REPLACE THE ELECTRODE BELT, BUT THE PATIENT DECLINED. SUPPORT SHIPPED AN ELECTRODE BELT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR