BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3940358 · Received April 17, 2014

    Report

    Report Number
    3008642652-2014-01194
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 WOULD NOT POWER ON. THE CAUSE OF THE INABILITY TO POWER ON WAS LIKELY A RAM FAILURE (U100 AND U101) ON CA BOARD SN (B)(4). THE RAM COMPONENTS LIKELY HAD AN INTERMITTENT BGA CONNECTION. 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 PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    DURING INVESTIGATION INTO A (B)(6) MONITOR WHICH WAS RETURNED FOR AN UNRELATED ISSUE, A REPORTABLE PROBLEM WAS DISCOVERED. THE MONITOR WAS RESETTING. THE MONITOR WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235605 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA