BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2033455 · Received March 23, 2011

    Report

    Report Number
    3002158293-2011-00349
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 22, 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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS DON'T WORK) HAS BEEN CONFIRMED. UPON VISUAL INSPECTION, IT WAS FOUND THAT THE END CAP WAS SEPARATED FROM THE MONITOR CASE AND THE WHITE CABLE RUNNING FROM THE COMPUTER/ANALOG PCA BOARD TO THE AUXILIARY BOARD WAS UNPLUGGED. THIS CAUSED THE RESPONSE BUTTONS NOT TO FUNCTION. THE ROOT CAUSE FOR THE END CAP SEPARATION CANNOT BE POSITIVELY IDENTIFIED BUT WAS PROBABLY THE RESULT OF A DROP OR EXCESSIVE FORCE. ONCE THE CABLE WAS REATTACHED, THE MONITOR WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE UNPLUGGED WIRE. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR