BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2140313 · Received June 15, 2011

    Report

    Report Number
    3008642652-2011-00057
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 15, 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 CONNECTOR PINS) HAS BEEN CONFIRMED. UPON EVALUATION, THE PINS IN THE ELECTRODE BELT'S TRUNK CABLE CONNECTOR WERE BENT. 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 TERRITORY MANAGER ASSISTING A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT WHILE THE PATIENT WAS CONNECTING THE BELT TO THE MONITOR, HE BENT THE 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 58 YR