BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4792399 · Received May 20, 2015

    Report

    Report Number
    3008642652-2015-03262
    Event Type
    Death
    Date Received
    May 20, 2015
    Date of Event
    April 6, 2015
    Report Date
    May 14, 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 EVAL OF MONITOR SN (B)(4) AND BELT SN (B)(4) IS COMPLETE. AS RECEIVED, THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT A PT. POST-SHOCK ASYSTOLE IS A KNOWN COMPLICATION OF DEFIBRILLATOR. MONITOR SN (B)(4) - REUSE. ELECTRODE BELT SN (B)(4), MANUFACTURE DATE: 06/2014 - INITIAL USE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PT PASSED AWAY ON (B)(6) 2015 AROUND 2:18 AM WHILE AT HOME. THE PT'S HUSBAND WAS PRESENT AT THE TIME AND IT WAS REPORTED THAT A POLICE OFFICER ARRIVED AND PERFORMED CPR. PER THE PT FLAG AND ECG DATA, AT 01:11:11 ON (B)(6) 2015 AN ARRHYTHMIA WAS DETECTED. THE PT'S RHYTHM WAS VF. A TREATMENT WAS DELIVERED DURING VF AT 01:11:49. THE POST-SHOCK RHYTHM WAS ASYSTOLE. POST-SHOCK ASYSTOLE IS A KNOWN COMPLICATION OF DEFIBRILLATION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE PT WAS TRANSPORTED TO THE HOSPITAL WHERE SHE PASSES AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328797 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death