BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2232947 · Received July 22, 2011

    Report

    Report Number
    3008642652-2011-00281
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 17, 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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (MONITOR WILL NOT BOOT PAST SPLASH SCREEN) HAS BEEN CONFIRMED. UPON EVALUATION THE FLASH MEMORY PROGRAMMING WAS FOUND TO BE CORRUPT. THE CAUSE FOR THE CORRUPT PROGRAMMING CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE CORRUPT PROGRAMMING. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE SON OF (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THE PATIENT'S MONITOR TURNED OFF AND THEN CAME BACK ON BUT IS STUCK ON THE LIFEVEST SCREEN. THE PATIENT 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 65 YR