BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2243750 · Received July 29, 2011

    Report

    Report Number
    3008642652-2011-00321
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 29, 2011
    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 (WON'T POWER UP) HAS BEEN CONFIRMED. UPON EVALUATION, IT WAS FOUND THAT THE FLASH MEMORY CHIPS (COMPONENTS U102 AND U105) WERE CORRUPT AND NEEDED REPLACED. IN ADDITION, IT WAS ALSO FOUND THAT THE SD RAM (SYNCHRONOUS DYNAMIC RANDOM ACCESS MEMORY) CHIPS (COMPONENTS U100 AND U101) WERE CORRUPT AND NEEDED REPLACED. A DEFECTIVE RAM WOULD PREVENT THE FLASH MEMORY FROM LOADING, THUS NOT POWERING UP THE MONITOR. THE ROOT CAUSE OF THE DEFECTIVE FLASH MEMORY AND DEFECTIVE SD RAM CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPT MEMORY. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WOULD NOT POWER UP. PATIENT WAS PROVIDED WITH 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 50 YR