BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1970477 · Received January 19, 2011

    Report

    Report Number
    3002158293-2011-00063
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    October 1, 2010
    Report Date
    January 17, 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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 101) WAS CONFIRMED. UPON EVALUATION, THE UNIT SHOWED CODE 101 (AV INCOMPATIBLE) AND WOULD NOT PROGRESS FURTHER WHEN BOOTED UP. THE ROOT CAUSE FOR THE WRENCH SERVICE CODE CANNOT BE POSITIVELY DETERMINED BUT IS LIKELY DUE TO EITHER A FAULTY DIGITAL SIGNAL PROCESSOR OR DEFECTIVE FLASH MEMORY. BOTH COMPONENTS ARE NOW OBSOLETE FOR THE 3100 MODEL, SO THE DEFECTIVE COMPONENT COULD NOT BE REPLACED AND TESTED TO PERFORM ROOT CAUSE ANALYSIS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENT. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR DISPLAYED A CODE 101 (AV INCOMPATIBLE). THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR