BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1001288 · Received February 19, 2008

    Report

    Report Number
    3002158293-2008-00059
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE MONITOR WAS FOUND TO HAVE A FRONT RESPONSE BUTTON SWITCH THAT WAS DEFECTIVE. THE ROOT CAUSE OF THE RESPONSE BUTTON FAILURE WAS THE METAL DOME HAD ROTATED AND SHIFTED WITHIN THE SWITCH BODY. THIS PREVENTED PROPER ELECTRICAL CONTACT BETWEEN THE CENTER CONDUCTOR PAD AND THE FOUR CORNER CONDUCTOR PADS WHEN THE SWITCH WAS DEPRESSED. THE CAUSE OF THE ROTATED/SHIFTED DOME WAS DETERMINED TO BE DELAMINATION OF THE SPACER LAYER WITHIN THE SWITCH. THE RESPONSE BUTTON WAS REPAIRED AND THE MONITOR WAS RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE FAULTY RESPONSE BUTTON. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE DAUGHTER OF A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE DEVICE WOULD NOT POWER UP. SHE STATED THAT WHEN THE BATTERY PACK WAS PLACED IN THE SYSTEM, THE BOOT UP PROCESS BEGAN, BUT THE RESPONSE BUTTONS DO NOT PUT THE DEVICE INTO MONITORING MODE. A LIFECOR PT SERVICES REPRESENTATIVE (PSR) VISITED THIS SAME DAY TO REPLACE THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR