BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3940359 · Received April 17, 2014

    Report

    Report Number
    3008642652-2014-01165
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 107) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WAS ABLE TO PROPERLY DETECT AND TREAT. HOWEVER, UPON EVAL, THE MONITOR WAS EXPERIENCING ABNORMAL SHUTDOWNS WAS LIKELY AN INTERMITTENT CONNECTION AT BGA COMPONENT U1003 (PLD) ON CA BOARD SN (B)(4). THE SUSPECT INTERMITTENT CONNECTION IS LIKELY DUE TO A FRACTURED BGA 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 CURRENTLY UNDERWAY. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A SERVICE CODE 107. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235937 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR