BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2110345 · Received April 21, 2011

    Report

    Report Number
    3002158293-2011-00458
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 20, 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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS ARE UNABLE TO ACTIVATE THE SYSTEM) HAS BEEN CONFIRMED. AS RECEIVED, THE REAR RESPONSE BUTTON WAS FOUND TO BE DEFECTIVE. THE ROOT CAUSE OF THE DEFECTIVE RESPONSE BUTTON CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE INOPERATIVE RESPONSE BUTTON. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE SYSTEM WILL NOT POWER ON CORRECTLY. HE STATED THAT THE RESPONSE BUTTONS ARE NOT ACTIVATING THE MONITOR. 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 DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR