BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2000007 · Received February 18, 2011

    Report

    Report Number
    3002158293-2011-00150
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    September 2, 2010
    Report Date
    February 7, 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 EVAL SUMMARY: EVAL OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (LOOSE BELT CONNECTOR) HAS BEEN CONFIRMED. THE ELECTRODE BELT CONNECTOR LOCKING NUT WAS MISSING. THE ROOT CAUSE FOR THE MISSING LOCKING NUT WAS NOT POSITIVELY IDENTIFIED, BUT WAS LIKELY DUE TO EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE TERRITORY MANAGER ASSISTING A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S ELECTRODE BELT CONNECTOR IS LOOSE AT THE TOP OF THE MONITOR. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR