BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2033477 · Received March 23, 2011

    Report

    Report Number
    3002158293-2011-00339
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 12, 2011
    Report Date
    March 18, 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 (DEFECTIVE RESPONSE BUTTON) HAS BEEN CONFIRMED. THE REAR RESPONSE BUTTON WAS FOUND TO BE DEFECTIVE. THE CAUSE OF THE DEFECTIVE RESPONSE BUTTON WAS DUE TO CORROSION ON THE CONNECTOR AND FLEX CONNECTOR. THE ROOT CAUSE OF THE CORROSION CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY DUE TO LIQUID INGRESS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE RESPONSE BUTTON. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE RESPONSE BUTTONS ON HER MONITOR WERE NOT WORKING. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILALTOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR