BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2002665 · Received February 9, 2011

    Report

    Report Number
    3002158293-2011-00146
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    December 12, 2010
    Report Date
    February 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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ABNORMAL SHUTDOWNS) HAS BEEN CONFIRMED. UPON EVAL, THE WIRING OF THE ELECTRODE BELT INTERFACE CONNECTOR WAS FOUND TO BE INTERMITTENT, CAUSING AN INTERMITTENT CONNECTION WITH AN ELECTRODE BELT. THE CAUSE FOR THE INTERMITTENT WIRING CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CONNECTOR. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE SON OF A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S MONITOR DISPLAYED A MESSAGE ASKING THE PT TO CONTACT ZOLL FOR SERVICING. REVIEWING THE PT'S DOWNLOAD REVEALED SERVICE CODE 107- ABNORMAL SHUTDOWNS. 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 CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR