BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2912897 · Received November 30, 2012

    Report

    Report Number
    3008642652-2012-03096
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER UP) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WOULD NOT POWER ON. THE CAUSE OF THE MONITOR NOT POWERING ON WAS A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON THE C/A BOARD SN (B)(4). THE FLASH MEMORY 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 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. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S MONITOR WAS NOT POWERING UP. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR