BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2212056 · Received July 8, 2011

    Report

    Report Number
    3008642652-2011-00168
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 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: DEVICE EVAL OF BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) HAS BEEN CONFIRMED. AS RECEIVED, THE TRUNK CABLE CONNECTOR WAS BROKEN. THE ROOT CAUSE OF THE DAMAGED CABLE CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE TRUNK CABLE CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT. DEVICE EVAL OF MONITOR (B)(4) IS CURRENTLY UNDER INVESTIGATION. SERVICING OF THIS MONITOR LED TO A REPORTABLE EVENT. THE MONITOR EXPERIENCED CONSTANT RESETS. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF THE ANALYSIS. NO ADVERSE EVENT RESULTED FROM THE CONSTANT RESETS. THE PT REPORTED AN UNRELATED EVENT AND RECEIVED A REPLACEMENT MONITOR. DEVICE MANUFACTURE DATE: (B)(4) - 06/2010.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THE ELECTRODE BELT WOULD NOT STAY CONNECTED TO THE MONITOR. THE PT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT AND REPLACEMENT MONITOR.

    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 30 YR