BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5054524 · Received September 3, 2015

    Report

    Report Number
    3008642652-2015-05267
    Event Type
    Death
    Date Received
    September 3, 2015
    Date of Event
    April 5, 2015
    Report Date
    August 31, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: ZOLL'S ATTEMPTS TO RECOVER THE PATIENT'S MONITOR AND ELECTRODE BELT HAVE BEEN UNSUCCESSFUL. MONITOR SN 07057376 AND ELECTRODE BELT SN (B)(4) HAVE NOT YET BEEN RETURNED TO ZOLL. THE LAST DATA DOWNLOAD WAS ON (B)(4) 2015 AT 2:15 AM. THERE ARE NO DOWNLOADED SOFTWARE FLAGS FROM AROUND THE TIME OF DEATH. AN ANALYSIS OF THE AVAILABLE DOWNLOADED DATA DID NOT IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE PATIENT DEATH. THERE IS NO INDICATION AT THIS TIME THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING.

    Description of Event or Problem · 1

    DURING A RETROACTIVE REVIEW OF DISTRIBUTOR INCIDENT FILES, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. THE PATIENT'S SISTER REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2015. IT WAS REPORTED THAT THE PASSING WAS CARDIAC RELATED AND THAT THE PATIENT WENT INTO CARDIAC ARREST. SHE REPORTED THAT THE LIFEVEST DID NOT WORK AND THAT EMS WOULD NOT PERFORM CPR BECAUSE THE LIFEVEST WAS ON. THE PATIENT'S SISTER REPORTED THAT SHE BEGGED THEM TO TAKE THE LIFEVEST OFF AND TO START CPR BUT EMS WOULD NOT. THE PATIENT WAS REPORTEDLY AT HOME PUTTING AWAY GROCERIES PRIOR TO THE EVENT. SHE WAS LATER TRANSPORTED TO AND PASSED AWAY AT THE HOSPITAL. IT WAS REPORTED THAT THE LIFEVEST DID ALARM BUT THE PATIENT HAD ALREADY PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585509 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death