BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823595 · Received May 1, 2014

    Report

    Report Number
    3008642652-2014-01341
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    February 28, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 (CODE 107) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WAS ABLE TO PROPERLY DETECT AND TREAT. HOWEVER UPON EVALUATION, THE MONITOR WAS EXPERIENCING ABNORMAL SHUTDOWNS. THE CAUSE OF THE ABNORMAL SHUTDOWNS WAS AN INTERMITTENT CONNECTION AT BGA COMPONENT U500 (DSP) ON THE CA BOARD. THE 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 PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261024 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR