BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10701492 · Received October 19, 2020

    Report

    Report Number
    3008642652-2018-07254
    Event Type
    Death
    Date Received
    October 19, 2020
    Date of Event
    July 6, 2018
    Report Date
    August 22, 2018
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MONITOR AND ELECTRODE BELT HAVE NOT BEEN RECOVERED FROM THE FIELD. THERE IS NO DOWNLOAD DATA AVAILABLE SURROUNDING THE DEATH. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD DOES NOT INDICATE ANY DEVICE MALFUNCTION. THE REVIEW OF THE DATA INDICATED THAT THE DEVICE POWERED ON NORMALLY AND WAS ABLE TO ACQUIRE THE PATIENT'S ECG SIGNAL ON THE LAST DAY OF USE CAPTURED IN THE DATA DOWNLOAD. NO DEFICIENCIES ALLEGED.

    Description of Event or Problem · 1

    ON 10/16/2020: RESUBMITTING THIS MDR AS PART OF AN INTERNAL AUDIT WHERE THE ELECTRONIC 3500A PDF FORM COULD NOT BE LOCATED. THE INTERNAL AUDIT INDICATES THAT THE ELECTRONIC 3500A FORM, WITHIN THE ESUBMITTER APPLICATION, WAS CREATED ON 08/22/2018. ACKNOWLEDGEMENTS 1, 2, AND 3 COULD NOT BE LOCATED. A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2018, AND MAY HAVE BEEN TREATED BY THE LIFEVEST. THE PATIENT WAS REPORTEDLY BEING DRIVEN HOME AT THE TIME OF THE EVENT. IT WAS REPORTED THAT PARAMEDICS PERFORMED RESUSCITATION EFFORTS, AND TRANSPORTED THE PATIENT TO THE HOSPITAL, AND THE PATIENT PASSED AWAY. IT WAS REPORTED BY EMS THAT "THE PATIENT APPEARED TO HAVE BEEN TREATED". THE PATIENT'S LAST AVAILABLE DOWNLOAD IS FROM 07/06/2018 AT 6:16 PM, BEFORE THE EVENT. THERE IS NO DOWNLOAD DATA AVAILABLE FROM THE PATIENT'S MONITOR, AS THE EQUIPMENT HAS NOT YET BEEN RECOVERED FROM THE FIELD. THE TREATMENT EVENT CANNOT BE CONFIRMED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159868 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| O