BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1913006 · Received November 18, 2010

    Report

    Report Number
    3002158293-2010-01222
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 23, 2010
    Report Date
    November 16, 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 WAS CONFIRMED. THE CAUSE OF THE BELT COMMUNICATIONS ERRORS WAS DUE TO A BROKEN TRUNK CABLE CONNECTOR. THE ROOT CAUSE OF THE BROKEN CONNECTOR CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. THE PT REC'D A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT SHE IS GETTING A CHECK BELT CONNECTION MESSAGE. THE PT'S ELECTRODE BELT WAS REPLACED.

    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 48 YR