BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 400 SYSTEM

    MDR report key: 4262490 · Received November 14, 2014

    Report

    Report Number
    3008642652-2014-03838
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    December 16, 2011
    Report Date
    November 10, 2014
    Manufacturer
    ZOLL MANUFACTURING CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) WAS COMPLETED. THE MONITOR WAS FULLY FUNCTIONAL UPON RECEIPT. ELECTRODE BELT SN (B)(4) WAS RETURNED FOR EVALUATION, BUT WAS UNABLE TO BE EVALUATED DUE TO EXTENSIVE BLOOD CONTAMINATION. THESE IS NO INDICATION OF ANY DEVICE MALFUNCTION. MONITOR SN (B)(4): 09/2010. ELECTRODE BELT SN (B)(4): 08/2009.

    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. THE NURSE OF A (B)(6) MALE PT CONTACTED ZOLL LOGISTICS AND REPORTED THAT THE PT PASSED AWAY ON (B)(6) 2011 AT 10:30 AM. THE PT WAS IN THE HOSPITAL AT THE TIME OF PASSING. THE NURSE ALSO REPORTED THAT THE PT BLED OUT WHILE IN THE HOSPITAL. AT 05:25 PM ON (B)(6) 2011, THE PT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT. DOUBLE COUNTING, LIKELY DUE TO THE LOW AMPLITUDE OF THE QRS COMPLEX ON THE SIDE-SIDE CHANNEL, CONTRIBUTED TO THE FALSE DETECTION. THE PT'S POST-SHOCK RHYTHM WAS A NORMAL SINUS RHYTHM. THE RESPONSE BUTTONS WERE NOT USED DURING THE EVENT. THE LIFEVEST WAS SHUT DOWN AT 8:54AM ON (B)(6) 2011. 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
    738822 LIFEVEST WCD 400 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death| H