BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 7704086 · Received July 19, 2018

    Report

    Report Number
    3008642652-2018-05903
    Event Type
    Malfunction
    Date Received
    July 19, 2018
    Date of Event
    June 8, 2018
    Report Date
    July 9, 2018
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    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 MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETS) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WOULD NOT FULLY POWER ON. UPON EVALUATION, THE MONITOR EXHIBITED A FLASH MEMORY FAILURE AT BGA COMPONENTS U102 AND U105 ON THE COMPUTER/ANALOG BOARD. THE ROOT CAUSE FOR THE FLASH MEMORY FAILURE COULD NOT BE POSITIVELY IDENTIFIED. THE MONITOR DESIGN CHANGE IN P010030/S039 WAS DETERMINED TO BE EFFECTIVE AT REDUCING THE OCCURRENCE OF FRACTURED BGA'S RESULTING FROM MECHANICAL STRAIN. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED A MONITOR AND REPORTED THAT THE MONITOR WAS RESETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544141 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1