BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1546335 · Received November 9, 2009

    Report

    Report Number
    3002158293-2009-00778
    Event Type
    Malfunction
    Date Received
    November 9, 2009
    Date of Event
    August 26, 2009
    Report Date
    November 6, 2009
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE ELECTRODE BELT WAS FOUND TO HAVE AN OPEN CONNECTION IN THE DISTRIBUTION NODE. R2 ON THE DISTRIBUTION NOSE BOARD WAS OPEN. THIS CAUSED AN INTERRUPTION IN THE DRIVEN GROUND SIGNAL. THIS RESULTED IN FALLOFF ON ALL ECGS AND THE "ADJUST BELT" MESSAGES. THE DISTRIBUTION NODE WAS REPAIRED AND THE ELECTRODE BELT WAS TESTED. BASELINE EVAL WAS PERFORMED AND THE CARDIAC SIGNAL NOW APPEARS NORMAL. THE ELECTRODE BELT WAS RETURNED TO STOCK. THE ROOT CAUSE OF THIS OPEN CONNECTION IS LIKELY DUE TO THE CARDIO-VERSION WITHOUT REMOVING THE ELECTRODE BELT. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HE WAS GETTING "ADJUST BELT" MESSAGES. SUPPORT CONFIRMED THAT THE SENSING ELECTRODES WERE ON THE BODY CORRECTLY. THE SPOUSE STATED THAT THE PT HAD A CARDIO-VERSION DONE TODAY AND THE HOSP DID NOT REMOVE THE DEVICE. SUPPORT SENT THE PT A REPLACEMENT ELECTRODE BELT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR