BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4262468 · Received November 14, 2014

    Report

    Report Number
    3008642652-2014-03848
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    January 9, 2014
    Report Date
    November 10, 2014
    Manufacturer
    ZOLL MANUFACTURING CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATIONS OF MONITOR (B)(4) AND ELECTRODE BELT (B)(4) WERE COMPLETED. THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL UPON RECEIPT. MONITOR SN (B)(4): 07/2013. ELECTRODE BELT (B)(4): 06/2013.

    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 TERRITORY MGR CONTACT A ZOLL CUSTOMER SUPPORT ON (B)(6) 2014 TO REPORT THAT A (B)(6) FEMALE PT PASSED AWAY. THE PT WAS REPORTED TO HAVE PASSED AWAY ON (B)(6) 2014, SOMETIME AFTER MIDNIGHT. THE PT REPORTEDLY ARRIVED AT THE EMERGENCY ROOM FEELING ILL AND WAS IN THE HOSPITAL AT THE TIME OF PASSING. PER REVIEW OF PT DOWNLOAD DATA, AT 15:36:10 ON (B)(6) 2014 THE PT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT. SCT AT 206 BPM CONTRIBUTED TO THE FALSE DETECTION. THE PT'S POST-SHOCK RHYTHM WAS INUS TACHYCARDIA AT 107 BPM. THE RESPONSE BUTTONS WERE NOT USED UNTIL AFTER THE TREATMENT WAS DELIVERED. THE LIFEVEST WAS SHUT DOWN AT 16:34:30 ON (B)(6) 2014. THE LIFEVEST WAS DEACTIVATED PRIOR TO PT PASSING. ZOLL CANNOT DEFINITIVELY RULE OUT THE INAPPROPRIATE TREATMENT AS A CONTRIBUTING CAUSE OF THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738895 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H