BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1893842 · Received November 1, 2010

    Report

    Report Number
    3002158293-2010-01139
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SCREECHING NOISE, WILL NOT POWER UP) HAS BEEN CONFIRMED. AS REC'D, THE MONITOR WAS FOUND TO HAVE DEFECTIVE COMPONENTS. THE FLASH MEMORY CHIPS (COMPONENTS U102 AND U105) WERE CORRUPT AND NEEDED TO BE REPLACED. THE ROOT CAUSE OF THE DEFECTIVE FLASH MEMORY CANNOT BE POSITIVELY IDENTIFIED. ONCE THE MEMORY CHIPS WERE REPLACED, THE MONITOR WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE CORRUPT MEMORY. THE PT REC'D A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) OLD MALE PT CALLED IN TO ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WAS MAKING A SCREECHING NOISE AND WOULD NOT POWER UP. SUPPORT ISSUE THE PT 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 39 YR