BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1894287 · Received November 4, 2010

    Report

    Report Number
    3002158293-2010-01142
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    September 25, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE ELECTRODE BELT CONNECTOR LOCKING NUT WAS MISSING. THE ROOT CAUSE FOR THE MISSING LOCKING NUT WAS NOT POSITIVELY IDENTIFIED. THE ELECTRODE BELT WAS OTHERWISE FULLY FUNCTIONAL AND COULD PROPERLY MONITOR A CARDIAC SIGNAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A PATIENT SERVICE REPRESENTATIVE (PSR) CALLED INTO ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT A PATIENT'S BELT COULD NOT CONNECT TO THE MONITOR BECAUSE THE CONNECTOR NUT FELL APART. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR