BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4805585 · Received May 27, 2015

    Report

    Report Number
    3008642652-2015-03455
    Event Type
    Death
    Date Received
    May 27, 2015
    Date of Event
    April 21, 2015
    Report Date
    May 25, 2015
    Manufacturer
    ZOLL LIFECOR 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 MONITOR SN (B)(4) AND BELT SN (B)(4)HAS BEEN COMPLETED. UPON EVALUATION, THERE MONITOR AND ELECTRODE BELT WERE ABLE TO DETECT AND TREAT. THE MONITOR SPEAKER WAS FOUND TO BE DEFECTIVE AND THE FRONT THERAPY ELECTRODE (TE) WAS LEAKING GEL. THE ROOT CAUSE OF THE DEFECTIVE SPEAKER CANNOT BE POSITIVELY IDENTIFIED. THE ROOT CAUSE OF THE GEL LEAK IS PHYSICAL ABUSE. THE DEFECTIVE SPEAKER AND THE LEAKING GEL WOULD NOT HAVE PREVENTED PROPER DETECTION AND TREATMENT. DEVICE MANUFACTURE DATE: MONITOR: 12/2013 ELECTRODE BELT: 05/2013.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A (B)(6) MALE PT PASSED AWAY NOT WEARING THE LIFEVEST. THE PT'S WIFE ALLEGED THAT THE PT WAS NOT WEARING THE LIFEVEST THAT DAY BECAUSE THERE WAS SOMETHING WRONG WITH THE ELECTRODE BELT AND WERE WAITING A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341391 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death