BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2953977 · Received January 15, 2013

    Report

    Report Number
    3008642652-2013-00121
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 7, 2012
    Report Date
    January 10, 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 (PULSE VOLTAGE FAULTS) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR FAILED INCOMING TESTING. THE CAUSE OF THE TEST FAILURE IS THE PULSE VOLTAGE FAULTS. THE CAUSE FO THE PULSE VOLTAGE FAULTS IS POOR COMMUNICATION FROM THE INTERCONNECT CABLE. THE CAUSE OF THE POOR COMMUNICATION IS IMPROPER SEATING OF THE CABLE. THE ROOT CASE OF THE IMPROPER SEATING OF THE CABLE CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE POOR COMMUNICATION. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO FOR UN RELATED ISSUE. DURING TROUBLESHOOTING, CUSTOMER SUPPORT REPORTED PULSE VOLTAGE FAULTS. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21902 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR