BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3973230 · Received June 5, 2014

    Report

    Report Number
    3008642652-2014-01719
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 17, 2014
    Report Date
    June 3, 2014
    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 EVALUATION OF THE ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 107 / CODE 204) WAS CONFIRMED. AS RECEIVED, THE BELT WAS FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT; HOWEVER, UPON EVAL, THE TRUNK CONNECTOR WAS UNABLE TO SECURELY LATCH WITH A TEST MONITOR. THE CAUSE OF THE CODE 107 IS LIKELY THE INSECURE CONNECTION BETWEEN THE ELECTRODE BELT AND MONITOR. THE CAUSE OF THE INSECURE CONNECTION IS LIKELY A DAMAGED CONNECTOR. THE ROOT CAUSE OF THE DAMAGED CONNECTOR CANNOT BE POSITIVELY IDENTIFIED. AN INVESTIGATION INTO THE TRUNK CONNECTOR LATCH ISSUE IS CURRENTLY UNDERWAY. NO ADVERSE EVENT RESULT FROM THE DAMAGED CONNECTOR. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT ABOUT A MALE PATIENT REPORTING SERVICE CODES 107 AND 204. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328722 LIFEVEST WCD 4000 SYSTEM MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1