BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2172341 · Received January 7, 2011

    Report

    Report Number
    3002158293-2011-00003
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 20, 2010
    Report Date
    January 6, 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 (BLANK SCREEN) HAS BEEN CONFIRMED. UPON EVALUATION IT WAS FOUND THAT THE FLASH MEMORY CHIPS (COMPONENTS U102 AND U105) WERE CORRUPT AND NEEDED TO BE REPLACED. THE ROOT CAUSE OF THE DEFECTIVE FLASH MEMORY CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPT MEMORY. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT NEITHER OF HIS BATTERIES WILL POWER UP THE MONITOR. 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 66 YR