BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2221443 · Received August 17, 2011

    Report

    Report Number
    3008642652-2011-00470
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 16, 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 (WILL NOT POWER ON) HAS BEEN CONFIRMED. THE CAUSE FOR THE INABILITY TO POWER ON IS CORRUPTED FLASH PROGRAMMING. THE ROOT CAUSE OF THE CORRUPTED FLASH CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPTED FLASH. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED A TERRITORY MGR, WHO THEN CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S MONITOR WILL NOT POWER ON. 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 39 YR