BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2212045 · Received July 8, 2011

    Report

    Report Number
    3008642652-2011-00132
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 30, 2011
    Report Date
    July 1, 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 (SERVICE CODE 107/ABNORMAL SHUTDOWN) HAS BEEN CONFIRMED. UPON EVALUATION, THE MONITOR WAS RESETTING, DUE TO THE ABNORMAL SHUTDOWNS. THE CAUSE OF THE ABNORMAL SHUTDOWNS WAS DUE TO CORRUPTED PROGRAMMING. THE ROOT CAUSE OF THE CORRUPTED PROGRAMMING CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPTED PROGRAMMING. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS DEVICE ALARMED THEN DISPLAYED A MESSAGE THAT THERE MAY BE A PROBLEM CUSTOMER SUPPORT REVIEWED THE PATIENT'S DOWNLOAD WHICH REVEALED A SERVICE CODE 107 AND ABNORMAL SHUTDOWN FLAGS. 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 59 YR