BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4698660 · Received April 14, 2015

    Report

    Report Number
    3008642652-2015-02057
    Event Type
    Death
    Date Received
    April 14, 2015
    Date of Event
    February 17, 2015
    Report Date
    April 11, 2015
    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: DEVICE EVALUATION OF MONITOR SN (B)(4) WAS COMPLETED. THE EQUIPMENT WAS FULLY FUNCTIONAL UPON EVALUATION. THERE WAS NO DEVICE MALFUNCTION. ELECTRODE BELT SN (B)(4) HAS NOT BEEN RETURNED FOR INVESTIGATION. THERE IS NO INDICATION AT THIS TIME THAT THE INAPPROPRIATE TREATMENT DURING ASYSTOLE CONTRIBUTED TO THE PT DEATH. NO DEFICIENCIES WERE ALLEGED. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4): 04/2013. ELECTRODE BELT SN (B)(4): 03/2012.

    Description of Event or Problem · 1

    A UNITED STATES DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A (B)(6) YEAR OLD PT PASSED AWAY ON (B)(6) 2015. THE LIFEVEST DELIVERED A 150J TREATMENT AT 14:02:12. THE RHYTHM AT THE TIME OF THE TREATMENT WAS ASYSTOLE, WHICH IS CONSIDERED A NON-TREATABLE RHYTHM. OVERSENSING OF SMALL CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTION. THE PT'S RHYTHM REMAINED ASYSTOLE. EMS ARRIVED ON THE SCENE AND REPORTED THAT THE LIFEVEST WAS ALARMING. THE LIFEVEST WAS REMOVED DURING EMS RESUSCITATION EFFORTS. THE PT SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247809 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death