BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5482726 · Received March 6, 2016

    Report

    Report Number
    3008642652-2016-01349
    Event Type
    Death
    Date Received
    March 6, 2016
    Date of Event
    February 10, 2016
    Report Date
    March 4, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) AND BELT SN (B)(4) IS CURRENTLY UNDERWAY BY ZOLL MANUFACTURING CORPORATION. EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. DOWNLOAD FAULT FLAGS WERE IDENTIFIED, BUT DOWNLOADING IS A SECONDARY FUNCTION OF THE DEVICE AND DOES NOT INTERFERE WITH THE DEVICE'S ABILITY TO DETECT AND TREAT A PATIENT. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE INAPPROPRIATE TREATMENT. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4): 08/27/2014 REUSE. ELECTRODE BELT SN (B)(4): 08/06/2015 INITIAL USE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR NOTIFIED ZOLL THAT A PATIENT PASSED AWAY ON (B)(6) 2016 WHILE WEARING THE LIFEVEST. THE PATIENT WAS IN THE HOSPITAL AT THE TIME. THE PATIENT WAS NOT CONSCIOUS AND HIS WIFE WAS PRESENT. PER REVIEW OF THE PATIENT'S DOWNLOADED FLAG DATA, THE PATIENT RECEIVED ONE INAPPROPRIATE DEFIBRILLATION ON (B)(6) 2016. THE LIFEVEST DELIVERED A TREATMENT AT 07:31:29. THE RHYTHM AT THE TIME OF THE TREATMENT WAS ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. THE PATIENT REMAINED IN ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY AFTER THE TREATMENT. OVERSENSING OF A SMALL CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTION. ASYSTOLE IS CONSIDERED A NON-SHOCKABLE RHYTHM. THERE IS NO INDICATION THAT THE TREATMENT DURING ASYSTOLE CAUSED OR CONTRIBUTED TO THE DEATH, AS THE PATIENT WAS ALREADY IN A NONLIFE- SUSTAINING RHYTHM BEFORE THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139082 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H