BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2243730 · Received July 29, 2011

    Report

    Report Number
    3008642652-2011-00325
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 29, 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 OF MONITOR (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR WAS FOUND TO BE MISSING THE FRONT RESPONSE BUTTON TACTILE. THE ROOT CAUSE FOR THE DEFECTIVE RESPONSE BUTTON CANNOT BE POSITIVELY DETERMINED BUT IS LIKELY DUE TO EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE RESPONSE BUTTON. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT AN UNRELATED EQUIPMENT ISSUE. UPON INVESTIGATION OF THE PATIENT'S MONITOR A REPORTABLE PROBLEM WAS DETECTED. THE PATIENT'S FRONT RESPONSE BUTTON WAS INOPERATIVE. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR