BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 3980642 · Received June 20, 2014

    Report

    Report Number
    3008642652-2014-01934
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (MONITOR ALARM AND OVERHEATING) WAS INVESTIGATED. UPON INVESTIGATION THE MONITOR PRODUCED DISCHARGE PROFILE, PULSE CURRENT, AND PULSE VOLTAGE FAULTS. THE CAUSE OF THE FAULTS IS CURRENTLY BEING INVESTIGATED. UPON COMPLETION OF A ROOT CAUSE INVESTIGATION A SUPPLEMENTAL REPORT WILL BE SENT. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S DAUGHTER CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THE PATIENT WAS EXPERIENCING ALARMS AND THE MONITOR WAS OVERHEATING. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364328 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR