BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4418642 · Received January 12, 2015

    Report

    Report Number
    3008642652-2014-05111
    Event Type
    Injury
    Date Received
    January 12, 2015
    Date of Event
    December 14, 2014
    Report Date
    December 29, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    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

    THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION. THE PT WAS ADMITTED TO THE HOSP AND WAS LATER FITTED WITH AN ICD. DEVICE EVAL WAS ACCOMPLISHED THROUGH A REVIEW OF THE PT'S DOWNLOADED DATA FILE. REVIEW OF THE DATA DOES NOT INDICATE ANY DEVICE MALFUNCTION RELATED TO THE DEFIBRILLATION EVENT. DEVICE MANUFACTURE DATE: MONITOR (B)(4), 02/02013 - REUSE. ELECTRODE BELT (B)(4), 05/2011 - REUSE. ADDITIONAL INAPPROPRIATE DEFIBRILLATION NARRATIVE: INAPPROPRIATE DEFIBRILLATIONS ARE AN ANTICIPATED RISK ASSOCIATED WITH THE USE OF THE LIFEVEST. PATIENTS ARE INSTRUCTED THROUGH ALARMS, VOICE MESSAGES, IFU, AND TRAINING TO PRESS THE RESPONSE BUTTONS TO PREVENT AN INAPPROPRIATE DEFIBRILLATION. (B)(4).

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. IT WAS REPORTED THAT THE PT WAS ENROUTE TO THE HOSP AT THE TIME OF TREATMENT. THE PT WAS INAPPROPRIATELY TREATED FOUR TIMES BETWEEN 08:51:51 AND 08:54:17. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE PT WAS ADMITTED TO THE HOSP AND WAS LATER FITTED WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (CD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27698 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O