BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1900078 · Received November 12, 2010

    Report

    Report Number
    3002158293-2010-01203
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    September 10, 2010
    Report Date
    November 10, 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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER UP) HAS BEEN CONFIRMED. UPON RECEIPT, 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. NO ADVERSE EVENT RESULTED FROM THE CORRUPT MEMORY. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A PT SERVICE REP (PSR) CALLED INTO ZOLL CUSTOMER SUPPORT WHILE WITH A (B)(4) OLD MALE PT TO REPORT THAT THE PT'S MONITOR STOPPED WORKING DURING THE INITIAL TRAINING SESSION. SUPPORT ISSUED 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 69 YR