BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2974598 · Received January 29, 2013

    Report

    Report Number
    3008642652-2013-00204
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 29, 2012
    Report Date
    January 18, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMERY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS NOT WORKING) WAS CONFIRMED. UPON INVESTIGATION THE METAL SWITCHES WERE MISSING FROM THE FRONT AND REAR RESPONSE BUTTONS. THE ROOT CAUSE FOR THE DAMAGED RESPONSE BUTTONS COULD NOT BE APPOSITIVELY IDENTIFIED BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR RESPONSE BUTTONS. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S NURSE CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S RESPONSE BUTTONS WERE NOT ACTIVATING THE MONITOR. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39796 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR