BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2160503 · Received July 1, 2011

    Report

    Report Number
    3008642652-2011-00124
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 30, 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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (B)(4) HAS BEEN CONFIRMED. UPON EVALUATION THE ELECTRODE BELT INTERFACE RECEPTACLE ON THE MONITOR WAS DEFECTIVE CAUSING SERVICE (B)(4). THE CAUSE FOR THE DEFECTIVE ELECTRODE BELT RECEPTACLE CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE BROKEN BELT INTERFACE RECEPTACLE ON THE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER MONITOR DISPLAYED A MESSAGE REQUESTING SHE CALL ZOLL. LATER IN THE CALL, SHE NOTICED SERVICE (B)(4). 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 71 YR