BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3940370 · Received April 17, 2014

    Report

    Report Number
    3008642652-2014-01129
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 9, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 (ABNORMAL SHUTDOWNS) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WAS RESETTING. THE CAUSE OF THE ABNORMAL SHUTDOWNS AND RESETS WAS A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON THE C/A BOARD SN (B)(4). AN INTERMITTENT CONNECTION WAS DISCOVERED AT PIN A25 OF THE FLASH MEMORY. 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 THROUGH ROUGH HANDLING. A ROOT CAUSE INVESTIGATION 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

    A (B)(6) YR OLD MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE MONITOR WOULD NOT POWER ON. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235567 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR