BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3080802 · Received April 12, 2013

    Report

    Report Number
    3008642652-2013-01005
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 8, 2013
    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 DO NOT ACTIVATE DEVICE) HAS BEEN CONFIRMED. UPON EVALUATION, THE REAR RESPONSE BUTTON CABLE WAS DAMAGED. THE CAUSE FOR THE INABILITY TO ACTIVATE THE DEVICE IS THE DAMAGED RESPONSE BUTTON CABLE. THE ROOT CAUSE FOR THE DAMAGED REAR RESPONSE BUTTON CABLE CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED RESPONSE BUTTON CABLE. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE RESPONSE BUTTONS WILL NOT ACTIVATE THE DEVICE. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157796 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR