BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2243654 · Received July 27, 2011

    Report

    Report Number
    3008642652-2011-00300
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 4, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 204) HAS BEEN CONFIRMED. AS RECEIVED, THE TRUNK CABLE WAS DAMAGED WITH A BROKEN WIRE INSIDE OF THE INSULATION. THE ROOT CAUSE OF THE DAMAGED CABLE CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. ONCE THE CABLE WAS REPLACED, THE BELT WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE DEVICE IS ALARMING HIM TO CALL FOR SERVICE. THE PATIENT REPORTED A SERVICE CODE 204 WAS ON THE MONITOR SCREEN. THE PATIENT 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 29 YR