BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6576013 · Received May 18, 2017

    Report

    Report Number
    3008642652-2017-04185
    Event Type
    Death
    Date Received
    May 18, 2017
    Date of Event
    April 9, 2017
    Report Date
    May 16, 2017
    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: MONITOR (B)(4) AND BELT (B)(4) HAVE NOT YET BEEN RECOVERED. THE INITIAL 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. THE SOFTWARE FLAG FILES DID NOT SUGGEST ANY DEVICE MALFUNCTION THAT WOULD CAUSE OR CONTRIBUTE TO THE EVENT. DEVICE MANUFACTURE DATE: MONITOR: 07/22/2016, BELT: 01/06/2015.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY WHILE WEARING THE LIFEVEST. RESCUE PERSONNEL WERE REPORTEDLY AT THE PATIENT'S HOME AND WERE ATTEMPTING CPR. REVIEW OF THE DOWNLOAD DATA INDICATES THAT THE LIFEVEST DELIVERED AN APPROPRIATE SHOCK AT 19:35:56 ON (B)(6) 2017 WHICH CONVERTED VT AT 220BPM TO ASYSTOLE. THE LIFEVEST THEN DETECTED A NON-TREATABLE RHYTHM AND THE PATIENT PASSED AWAY. THE PATIENT'S PHYSICIAN REPORTEDLY INDICATED THAT THE LIFEVEST FUNCTIONED PROPERLY DESPITE THE PATIENT'S PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358538 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| O