BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2082153 · Received April 28, 2011

    Report

    Report Number
    3002158293-2011-00467
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    December 12, 2010
    Report Date
    April 22, 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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BENT PINS) HAS BEEN CONFIRMED. UPON EVALUATION, PINS IN THE ELECTRODE BELT'S TRUNK CABLE CONNECTOR WERE BENT IS A SWIRL PATTERN. THE CAUSE FOR THE BENT PINS CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO THE CONNECTOR BEING FORCED INTO THE MONITOR WHILE THE PINS WERE MISALIGNED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT AN UNRELATED COMPLAINT. DURING SERVICING OF THE PATIENT'S ELECTRODE BELT, A REPORTABLE PROBLEM WAS DISCOVERED. THE BELT HAD BENT PINS IN THE CONNECTOR. THE PATIENT WAS PROVIDED WITH 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 45 YR