BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1972674 · Received January 20, 2011

    Report

    Report Number
    3002158293-2011-00058
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    November 16, 2010
    Report Date
    January 14, 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 EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 102) WAS CONFIRMED. UPON EVAL, CHARGE PROFILE FAULTS WERE SEEN, CAUSING THE SERVICE CODE 102. THE COMPUTER/ANALOG BOARD ON THE MONITOR HAD A DEFECTIVE SWITCHING REGULATOR COMPONENT, U1. THE R45 RESISTOR WAS ALSO DEFECTIVE. THE ROOT CAUSE OF THE DEFECTIVE U1 AND R45 CANNOT BE POSITIVELY DETERMINED, BUT IS LIKELY DUE TO A RANDOM COMPONENT FAILURE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENT. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) YEAR OLD MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT WAS RECEIVING ALARMS THE PREVIOUS NIGHT. A REVIEW OF THE PT'S DOWNLOAD REVEALED SEVERAL "SERVICE CODE DISPLAYED" ERRORS. THE PT WAS ISSUED 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 32 YR