BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2232966 · Received July 22, 2011

    Report

    Report Number
    3008642652-2011-00274
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 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 MONITOR SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (SERVICE CODE 204; CONNECT BELT MESSAGES) IS UNDER INVESTIGATION. UPON EVALUATION TEST ELECTRODE BELTS WERE ABLE TO COMMUNICATE WITH THE MONITOR; HOWEVER, WOULD NOT STAY PROPERLY ATTACHED TO THE MONITOR. THE CAUSE FOR THE BELTS NOT REMAINING ATTACHED TO THE MONITOR CANNOT BE POSITIVELY DETERMINED. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF ROOT CAUSE ANALYSIS. NO ADVERSE EVENT RESULTED. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A PATIENT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE FITTING A PATIENT TO REPORT A CODE 204. THE PATIENT WAS ISSUED A 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 44 YR