BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2240954 · Received August 9, 2011

    Report

    Report Number
    3008642652-2011-00407
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 9, 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 ELECTRODE BELT SN (B)(6) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SEVERAL CHECK BELT MESSAGES) HAS BEEN CONFIRMED. UPON EVALUATION, THE PCA BOARD IN THE ELECTRODE NODE NEAREST THE FRONT TE PAD WAS SHORTING THE -5V POWER SUPPLY. THE CAUSE FOR THE SHORTED POWER SUPPLY IS DUE TO A DEFECTIVE VOLTAGE COMPONENT (V2). NO ADVERSE EVENT RESULTED FROM THE ELECTRICAL SHORT. THE PATIENT RECEIVE A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT SEVERAL ADJUST BELT MESSAGES. THE PATIENT WAS PROVIDED WITH A NEW ELECTRODE BELT.

    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 69 YR