BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3171866 · Received May 24, 2013

    Report

    Report Number
    3008642652-2013-01421
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 23, 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 NOT WORKING) HAS BEEN CONFIRMED. UPON INVESTIGATION THE RESPONSE BUTTONS WERE NON-FUNCTIONAL. THE CAUSE FOR THE NON-RESPONSIVE BUTTONS WAS ISOLATED TO A DEFECTIVE REAR RESPONSE BUTTON CABLE. THE ROOT CAUSE FOR THE DEFECTIVE RESPONSE BUTTON CABLE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE RESPONSE BUTTON CABLE. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE SON OF A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE RESPONSE BUTTONS ARE THE PT'S MONITOR WERE NOT WORKING. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231612 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR