BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2110355 · Received April 21, 2011

    Report

    Report Number
    3002158293-2011-00465
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    February 26, 2011
    Report Date
    April 21, 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 BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204/COMMUNICATION ERRORS) HAS BEEN CONFIRMED. AS RECEIVED, THE TRUNK CABLE CONNECTOR WAS BROKEN. THE ROOT CAUSE OF THE BROKEN CONNECTOR CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. ONCE THE TRUNK WAS REPLACED, THE BELT WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE BROKEN CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT REVIEWED THE DOWNLOAD OF A (B)(6) FEMALE PATIENT WHICH REVEALED SEVERAL SERVICE CODE 204S AND BELT COMMUNICATION ERRORS. THE PATIENT WAS ISSUED 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 55 YR