BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4649045 · Received March 27, 2015

    Report

    Report Number
    3008642652-2015-01690
    Event Type
    Death
    Date Received
    March 27, 2015
    Date of Event
    February 23, 2015
    Report Date
    March 26, 2015
    Manufacturer
    ZOLL MANUFACTURING CORP
    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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) AND MONITOR SN (B)(4) ARE COMPLETE. AS RECEIVED, THE ELECTRODE BELT AND MONITOR WERE FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT. MONITOR (B)(4) - 04/2013 (REUSE), ELECTRODE BELT (B)(4) - 06/2011 (REUSE).

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A (B)(6) YEAR OLD FEMALE PT PASSED AWAY ON (B)(6) 2015 AT HOME WHILE NOT WEARING THE LIFEVEST. ON (B)(6) 2015 AROUND 10:00 AM, THE PT'S HOME NURSE CONTACTED THE DISTRIBUTOR TO INFORM THEM THAT THE PT HAD STOPPED USING THE LIFEVEST BECAUSE THE DEVICE WAS REPORTEDLY TOO TIGHT. BASED UPON THE DOWNLOADED DATA, THE PT STOPPED USING THE LIFEVEST ON (B)(6) 2015. AFTER LEARNING THAT THE PT WAS NOT WEARING THE DEVICE, THE DISTRIBUTOR SENT A REPRESENTATIVE TO VISIT THE PT AND FIT HER WITH A LARGER GARMENT. THE REPRESENTATIVE ARRIVED AT THE PT'S RESIDENCE AROUND 5:30 PM ON (B)(6) 2015, BUT THE PT HAD ALREADY PASSED. THERE IS NO FURTHER INFORMATION ABOUT THE NATURE OF THE PT'S PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204867 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death