BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1853468 · Received September 28, 2010

    Report

    Report Number
    3002158293-2010-00983
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 19, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL SUMMARY OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (TOP CAME OFF OF THE MONITOR CASE) HAS BEEN CONFIRMED. UPON INSPECTION, IT WAS FOUND THAT THE END CAP WAS SEPARATED FROM THE MONITOR CASE. THE WHITE CABLE WAS UNPLUGGED FROM J2008 ON THE AUXILIARY BOARD. THE ROOT CAUSE OF THE DAMAGED MONITOR WAS LIKELY A RESULT OF EXCESSIVE FORCE. ONCE THE CABLE WAS RECONNECTED, THE MONITOR WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE UNPLUGGED CABLE IN THE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE PT SVC REP (PSR) ASSISTING A (B)(6) FEMALE PT CALLED IN TO ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE TOP CAME OFF THE PT'S MONITOR. THE PT RECEIVED 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 58 YR