BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4564585 · Received February 27, 2015

    Report

    Report Number
    3008642652-2015-01035
    Event Type
    Death
    Date Received
    February 27, 2015
    Date of Event
    January 22, 2015
    Report Date
    February 26, 2015
    Manufacturer
    ZOLL MANUFACTURING CORP
    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 OF MONITOR SN (B)(4) AND BELT SN (B)(4) HAVE BEEN COMPLETED. UPON EVALUATION, BOTH THE MONITOR AND ELECTRODE BELT WERE ABLE TO PROPERLY DETECT AND TREAT. ONE OF THE BLISTERS OF THE REAR 1-WIRE TE DID NOT DEPLOY, HOWEVER, THIS DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THE PT EXPERIENCED TREATMENT SHOCK DURING ASYSTOLE. IN ADDITION, THE REMAINING DEPLOYED SURFACE AREA IS SUFFICIENT FOR EXTERNAL DEFIBRILLATION. MONITOR (B)(4): 02/2014, ELECTRODE BELT (B)(4): 02/2014.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL ON (B)(6) 2015 TO REPORT THAT A PT PASSED AWAY WHILE WEARING THE LIFEVEST ON (B)(6) 2015. REVIEW OF THE PT'S DOWNLOADED DATA INDICATES THAT THE PT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT CONSISTING OF 5 SHOCKS DURING ASYSTOLE. CPR ARTIFACT CONTRIBUTED TO THE FALSE DETECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140784 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| O