BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1082474 · Received July 22, 2008

    Report

    Report Number
    3002158293-2008-00321
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 21, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR HAD BEEN COMPLETED. THE REPORTED PROBLEM (CODE 29) WAS CONFIRMED. THE CAUSE OF THE REPORTED PROBLEM WAS A DEFECTIVE CAPACITOR BANK WITHIN THE MONITOR. THE CAPACITORS COULD NOT CHARGE. R46, THE DISCHARGE RESISTOR, WAS ALSO BURNT. THE DEFIBRILLATOR BOARD WAS REPLACED. THE MONITOR WAS RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE DEFECTIVE CAPACITOR BANK IS UNKNOWN, BUT IS LIKELY RANDOM COMPONENT FAILURE. NO ADVERSE EVENT RESULTED FROM THE MONITOR FAILURE. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A 46 YEAR OLD FEMALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT SHE WAS GETTING A SERVICE 29. SERVICE CODE 29 IS A CHARGE PROFILE FAULT. SUPPORT SENT THE PATIENT A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR