BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1372369 · Received February 20, 2009

    Report

    Report Number
    3002158293-2009-00083
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    January 8, 2009
    Report Date
    February 18, 2009
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT (B) (4) HAS BEEN COMPLETED. THE ELECTRODE BELT WAS FOUND TO HAVE AN OPEN CONNECTION IN THE DISTRIBUTION NODE. THERE WAS A WIRE THAT CAME OFF A SOLDER PAD. THE WIRE TO THE P4 LEAD WAS BROKEN OFF. THIS MADE THE SYSTEM THINK THE BELT WAS NOT SITTING CORRECTLY ON THE BODY. 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 LIKELY DUE TO EXCESSIVE FORCE ON THE ELECTRODE BELT CABLE. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE PATIENT SERVICES REPRESENTATIVE (PSR) OF A (B) (6) MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT SHE COULD NOT GET THE DEVICE TO BASELINE. SHE STATED THAT THE DEVICE BEGINS TO RECORD AND THEN BONGS AND DISPLAYS THE "ADJUST BELT" MESSAGE. THE DOWNLOAD REVEALS A FLAT LINE ON THE FRONT-TO-BACK CHANNEL. SUPPORT SENT ANOTHER PSR TO THE PATIENT TO 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR