BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1760613 · Received July 12, 2010

    Report

    Report Number
    3002158293-2010-00721
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 12, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR (B)(4) HAS BEEN COMPLETED. UPON INSPECTION, THE MONITOR WAS UNABLE TO POWER ON. THE CAUSE OF THE MONITOR NOT POWERING ON WAS DUE TO A CORRUPTED FLASH. THE ROOT CAUSE OF THE CORRUPTED FLASH CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT WAS PROVIDED WITH A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    DURING THE INVESTIGATION OF MONITOR (B)(4) FOR AN UNRELATED COMPLAINT, A REPORTABLE PRODUCT PROBLEM WAS DISCOVERED. THE MONITOR WAS UNABLE TO POWER ON. THE PT WAS PROVIDED WITH 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 41 YR