BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6196221 · Received December 21, 2016

    Report

    Report Number
    3008642652-2016-09405
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    November 20, 2016
    Report Date
    December 21, 2016
    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: DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAS NOT YET BEEN COMPLETED. THE INITIAL DEVICE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO 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.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT PASSED AWAY ON (B)(6) 2016 WHILE WEARING THE LIFEVEST. THE PATIENT WAS IN THE HOSPITAL AT THE TIME OF THE EVENT. THE LIFEVEST TREATED THE PATIENT AND HOSPITAL STAFF ATTEMPTED TO RESUSCITATE THE PATIENT. A REVIEW OF DEVICE DOWNLOAD INFORMATION REVEALS THAT THE LIFEVEST DELIVERED A TREATMENT AT 11:18:48 PM. THE ECG RECORDING AT THE TIME OF THE TREATMENT REVEALS CPR ARTIFACT WITH PULSELESS ELECTRICAL ACTIVITY. THE CPR ARTIFACT CONTRIBUTED TO THE FALSE DETECTIONS. THE ELECTRODE BELT WAS DISCONNECTED AT 11:19:35 PM. THERE IS NO INDICATION THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE DEATH, AS THE PATIENT WAS ALREADY IN A NON-LIFE-SUSTAINING RHYTHM PRIOR TO THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845602 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death