BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843859 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02776
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    August 31, 2012
    Report Date
    October 18, 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 EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 202) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WAS DISPLAYING CODE 202. THE CAUSE OF THE SVC CODE 202 WAS A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON THE C/A BOARD. INTERMITTENT CONNECTIONS WERE DISCOVERED AT U102 AND U105. THE INTERMITTENT CONNECTORS ARE LIKELY DUE TO FRACTURED SOLDER CONNECTORS 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 MEMORY. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A CODE 202 - PT PARAMETERS CORRUPT. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR