BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4250073 · Received November 7, 2014

    Report

    Report Number
    3008642652-2014-03728
    Event Type
    Death
    Date Received
    November 7, 2014
    Date of Event
    September 13, 2014
    Report Date
    November 6, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) WAS COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH) WAS INVESTIGATED. AS RECEIVED, THE MONITOR WAS FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT. ELECTRODE BELT SN (B)(4) HAS NOT YET BEEN RETURNED TO ZOLL. REVIEW OF THE DATA DOES NOT INDICATE ANY DEVICE MALFUNCTION. REVIEW OF THE EVENT REVEALS THAT THE INITIAL LIFE-THREATENING RHYTHM WAS ASYSTOLE. THE PT EXPERIENCED TWO INAPPROPRIATE DEFIBRILLATIONS DURING ASYSTOLE. OVERSENSING OF SMALL ARTIFACT CONTRIBUTED TO THE FALSE DETECTIONS. ELECTRODE BELT (B)(4): 08/2013.

    Description of Event or Problem · 1

    A U.S. DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PT PASSED AWAY WHILE WARING THE LIFEVEST. THE PT WAS REPORTEDLY LAYING UNCONSCIOUS ON THE FLOOR WITH THE LIFEVEST ALARMING TO 'START CPR AND CALL 911'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719430 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death