BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6432672 · Received March 24, 2017

    Report

    Report Number
    3008642652-2017-02428
    Event Type
    Death
    Date Received
    March 24, 2017
    Date of Event
    February 18, 2017
    Report Date
    March 23, 2017
    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: MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) WERE RETURNED ZOLL MANUFACTURING ON 3/2/2017 EVALUATION IS CURRENTLY UNDERWAY. DEVICE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES (ATTACHED) 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 INAPPROPRIATE TREATMENT OR PATIENT DEATH. MANUFACTURE DATES: MONITOR SN (B)(4): 11/30/2015, ELECTRODE BELT SN (B)(4): 5/25/2012.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2017 WHILE WEARING THE LIFEVEST. PRIOR TO PASSING, THE PATIENT RECEIVED THREE INAPPROPRIATE TREATMENTS. THE PATIENT WAS REPORTEDLY IN A SKILLED NURSING FACILITY AND NOT CONSCIOUS AT THE TIME OF THE EVENT. ALL THREE OF THE TREATMENTS WERE DELIVERED WHILE THE PATIENT WAS IN ASYSTOLE. THE POST-SHOCK RHYTHM WAS ALSO ASYSTOLE FOR ALL OF THE TREATMENTS. THE RESPONSE BUTTONS WERE PRESSED INTERMITTENTLY DURING THE EVENT BUT NOT DURING THE TREATMENT SEQUENCE THAT RESULTED IN THE DEFIBRILLATION SHOCKS. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. OVERSENSING OF LOW-AMPLITUDE CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTION. THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215324 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| O