BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 4176772 · Received October 1, 2014

    Report

    Report Number
    3008642652-2014-03091
    Event Type
    Death
    Date Received
    October 1, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    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) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY EXPIRED, LIFEVEST DID NOT WORK) WAS NOT CONFIRMED. UPON INVESTIGATION THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL. THE LIFEVEST FLAG FILES WERE REVIEWED, AND THERE IS NO INDICATION OF ANY BATTERY FAILURE PRIOR TO THE PT DEATH. THE BATTERIES WERE FUNCTIONING NORMALLY AND WERE NOT DEPLETED. THERE IS NO INDICATION OF ANY LIFEVEST MALFUNCTION. THE LIFEVEST WAS DEACTIVATED AT 21:11:43 ON (B)(6) 2014. THE PT PASSED AWAY ON (B)(6) 2014. THE LIFEVEST WAS NOT IN USE AT THE TIME OF DEATH. THERE IS NO INDICATION THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PT DEATH. MONITOR SN (B)(4) - (B)(6) 2011; ELECTRODE BELT SN (B)() - (B)(6) 2013.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR NOTIFIED ZOLL MANUFACTURING CORP ON (B)(4) 2014 THAT A (B)(6) YR OLD MALE PT PASSED AWAY ON (B)(6) 2014 WHILE IN THE HOSPITAL. THE EXACT TIME OF DEATH IS UNK. THE PT WAS REPORTEDLY NOT WEARING THE LIFEVEST AT THE TIME OF DEATH. THE PT'S FRIEND ALLEGED THAT, PRIOR TO THE PT PASSING, THE LIFEVEST DID NOT WORK AND HAD A DEAD BATTERY. SHE REPORTED THAT THE BATTERY WAS FULLY CHARGED EARLIER IN THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611530 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death