BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 4262473 · Received November 14, 2014

    Report

    Report Number
    3008642652-2014-04116
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    June 14, 2009
    Report Date
    November 13, 2014
    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 ELECTRODE BELT SN (B)(4) WAS COMPLETED. THE MONITOR AND ELECTRODE BELT WERE BOTH FULLY FUNCTIONAL UPON RECEIPT. MONITOR SN (B)(4): 10/2006 (REUSE). ELECTRODE BELTS SN (B)(4): 06/2008 (REUSE).

    Description of Event or Problem · 1

    DURING A RETROACTIVE REVIEW OF PAST COMPLAINTS FOR POTENTIAL ADVERSE EVENTS, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. A ZOLL ACCOUNT COORDINATOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) FEMALE PT PASSED AWAY ON (B)(6) 2009. PRIOR TO THE PT'S PASSING, THE PT RECEIVED A DEFIBRILLATION AT 00:07:17 ON (B)(6) 2009. ATRIAL FIBRILLATION WITH ABERRANT CONDITION CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE PT WAS TAKEN TO THE HOSPITAL WHERE SHE PASSED AWAY LATER THAT DAY. THE PT WAS NOT WEARING THE LIFEVEST AT TIME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738836 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death