BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6063190 · Received October 28, 2016

    Report

    Report Number
    3008642652-2016-07851
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 26, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE BATTERY CHARGER/MODEM WAS UNABLE TO FULLY POWER ON. UPON EVALUATION, THE CHARGER/MODEM EXHIBITED A FLASH MEMORY FAILURE AT BGA COMPONENTS U102 AND U105 ON THE C/A BOARD. THE ROOT CAUSE FOR THE FLASH MEMORY FAILURE COULD NOT BE POSITIVELY IDENTIFIED. THE BATTERY CHARGER DESIGN CHANGE IN P010030/S041 WAS DETERMINED TO BE EFFECTIVE AT REDUCING THE OCCURRENCE OF FRACTURED BGA'S RESULTING FROM MECHANICAL STRAIN. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED BATTERY CHARGER/MODEM SN (B)(4) AND REPORTED THAT THE CHARGER'S BACKLIGHT WAS NON-FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714132 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1