BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1150117 · Received August 29, 2008

    Report

    Report Number
    3002158293-2008-00420
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ZOLL LIFECOR 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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT HAS BEEN COMPLETED. THE ELECTRODE BELT WAS FOUND TO HAVE AN OPEN CONNECTION IN THE DISTRIBUTION NODE. R2 A RESISTOR IN THE DISTRIBUTION NODE HAD BECOME OPEN. 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 RANDOM COMPONENT FAILURE. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A LIFECOR PATIENT SERVICES REPRESENTATIVE (PSR) OF A 54 MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE SYSTEM KEPT ALARMING "ADJUST BELT". SUPPORT ADVISED THE PSR TO REMOVE THE BATTERY PACK AND ENSURE ALL COMPONENTS ARE FITTING CORRECTLY. THE PSR DID THIS AND THE SYSTEM WAS STILL ALARMING TO "ADJUST BELT". THE PSR DOWNLOADED, AND THE DOWNLOAD REVEALED FALL OFF AND NOISE. SUPPORT HAD THE PSR REPLACE THE ELECTRODE BELT.

    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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR