BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2212044 · Received July 8, 2011

    Report

    Report Number
    3008642652-2011-00171
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 3, 2011
    Report Date
    July 8, 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 204) HAS BEEN CONFIRMED. UPON EVALUATION, IT WAS DISCOVERED THAT COMPONENT Y402 (SMD CRYSTAL OSCILLATOR) ON THE CA BOARD WAS DEFECTIVE. THE DEFECTIVE Y402 COMPONENT PREVENTED THE MONITOR FROM BEING ABLE TO COMMUNICATE WITH THE BELT. THE ROOT CAUSE OF THE DEFECTIVE Y402 COMPONENT CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENT. THE PATIENT RECEIVED A REPLACEMENT MONITOR. NO PROBLEMS WERE DISCOVERED WITH THE PATIENT'S ELECTRODE BELT.

    Description of Event or Problem · 1

    A PATIENT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) MALE PATIENT TO REPORT THAT SHE WAS UNABLE TO PLACE THE PATIENT'S MONITOR INTO PROGRAMMING MODE BECAUSE SERVICE CODE 204 APPEARED ON THE SCREEN. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT AND 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 55 YR