BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2232984 · Received July 20, 2011

    Report

    Report Number
    3008642652-2011-00261
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ZOLL LIFECOR CORP
    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 (SERVICE CODE 204) HAS BEEN CONFIRMED. UPON INSPECTION THE BELT CONNECTOR MOUNTING TABS ON THE MONITOR BELT RECEPTACLE WERE SNAPPED OFF, CAUSING THE BELT CONNECTOR TO HAND LOOSE. THE ROOT CAUSE OF THE DEFECTIVE MONITOR CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO PHYSICAL TRAUMA. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT HER MONITOR WAS SHOWING A SERVICE CODE 204. THE PT 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 CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR