BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1951183 · Received December 13, 2010

    Report

    Report Number
    3002158293-2010-01313
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    October 29, 2010
    Report Date
    December 8, 2010
    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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (GELLED BELT) HAS BEEN CONFIRMED. UPON RECEIPT, NO GEL WAS RELEASED OR LEAKING FROM THE BELT. THE CABLE FROM THE REAR THERAPY ELECTRODE PAD TO THE DISTRIBUTION NODE WAS PULLED OUT OF THE DISTRIBUTION NODE, DISCONNECTING THE GEL FIRE WIRES. THE CONSTANT "ADD GEL" ALARMS EXPERIENCED BY THE PT WERE CAUSED BY BROKEN GEL-FIRE LINES. THE ROOT CAUSE OF THE BROKEN WIRES CANNOT BO POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. ONCE THE WIRES WERE REATTACHED, THE ELECTRODE BELT WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S WIFE CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THE PATIENT'S DEVICE WAS ALARMING TO ADD GEL. THE PATIENT'S WIFE ALSO STATED THAT THERE WAS NO BLUE GEL RELEASED. THE PT WAS PROVIDED WITH 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 62 YR