BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2221462 · Received August 17, 2011

    Report

    Report Number
    3008642652-2011-00449
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 12, 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 (DAMAGED RESPONSE BUTTON-NONFUNCTIONAL) HAS BEEN CONFIRMED. AS RECEIVED, THE FRONT RESPONSE BUTTON COVER WAS TORN AND THE SWITCH WAS DEFECTIVE. THE CAUSE FOR THE NONFUNCTIONAL RESPONSE BUTTON WAS DAMAGE TO THE SWITCH. THE FRONT RESPONSE BUTTON COVER WAS TORN, EXPOSING THE SWITCH TO THE ENVIRONMENT. THE SOURCE OF THE DAMAGE CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE SWITCH. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT'S WIFE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THE PT'S RESPONSE BUTTON HAD FALLEN OFF AND NOW COULD NOT PRESS IT. 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 77 YR