BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4232317 · Received September 17, 2014

    Report

    Report Number
    3008642652-2014-02907
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ZOLL MANUFACTURING 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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR FAILED INCOMING FUNCTIONALITY TESTING. UPON INVESTIGATION, THE MONITOR WOULD NOT POWER UP. THE CAUSE OF THE INABILITY TO POWER ON WAS LIKELY A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON THE C/A BOARD SN (B)(4). THE FLASH MEMORY LIKELY HAD AN INTERMITTENT CONNECTION, WHICH WAS DISCOVERED THROUGH THE USE OF A FLASH MEMORY TEST. DURING THE FLASH MEMORY TEST THE MONITOR PRODUCED A SEGMENTATION FAULT. THE INTERMITTENT CONNECTION WAS LIKELY INDUCED BY MECHANICAL STRESS. THE EXACT SOURCE OF THE MECHANICAL STRESS HAS NOT BEEN POSITIVELY IDENTIFIED BUT THE INTERMITTENT CONNECTION MAY HAVE BEEN ACCELERATED FOR THE FRACTURE IS CURRENTLY UNDERWAY. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    WHILE EVALUATING A (B)(6) PATIENT'S MONITOR FOR AN UNRELATED ISSUE A REPORTABLE PROBLEM WAS DISCOVERED. THE MONITOR WOULD NOT POWER ON. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573867 LIFEVEST WCD 4000 SYSTEM WEARABLE CARIDOVERTER DEFIBRILLATOR, MVK MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA