BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3896983 · Received May 16, 2014

    Report

    Report Number
    3008642652-2014-01478
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 206) HAS BEEN CONFIRMED. FLAG DATA FROM THE MONITOR SHOWED THAT THE MONITOR WAS INTERMITTENTLY DISPLAYING A SERVICE CODE 206. THE CAUSE OF THE SERVICE CODE ON AS AN MD5 FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON THE C/A BOARD. AN INTERMITTENT CONNECTION WAS DISCOVERED ON THE FLASH MEMORY CHIPS. THE INTERMITTENT CONNECTION IS LIKELY DUE TO A FRACTURED SOLDER CONNECTION INDUCED BY MECHANICAL STRESS. THE EXACT SOURCE OF THE MECHANICAL STRESS HAS NOT BEEN POSITIVELY IDENTIFIED BUT THE FRACTURED CONNECTION MAY HAVE BEEN ACCELERATED THROUGH ROUGH HANDLING. A ROOT CAUSE INVESTIGATION IS UNDERWAY. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENTS. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    DOWNLOAD DATA REVEALED THAT A (B)(6) MALE PATIENT WAS RECEIVING A SERVICE CODE 206. ZOLL CUSTOMER SUPPORT CONTACTED THE PATIENT AND ISSUED HIM A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294531 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR